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Stop using now Medical device recall · FDA · Published April 11, 2018

Arrow 4Fr Catheter Clamp Recall: Unsealed Packaging Risk

Arrow recalls 4Fr Catheter Clamps with Fastener (Product Code CC-00004) due to potential unsealed packaging that may compromise sterility. Affected units include specific lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2006-2018Medical deviceArrow ›
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Recalling firmArrow International Inc2400 Bernville Rd · Reading, PA 19605-9607
✎ GovInfoNow plain-language explainer

What happened, in plain English

Arrow is recalling 4Fr Catheter Clamps with Fastener (Product Code CC-00004) because the packaging might not be sealed properly, which could lead to contamination. This is a serious risk for medical use, especially in hospitals or clinics where sterile procedures are critical. Read more at govinfonow.com/recall/71404-arrow-4fr-catheter-clamp-recall-unsealed-packaging-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/71404-arrow-4fr-catheter-clamp-recall-unsealed-packaging-risk · Updated August 21, 2026 · FDA enforcement record: FDA #Z-2006-2018

Cite this page

“Arrow 4Fr Catheter Clamp Recall: Unsealed Packaging Risk.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71404-arrow-4fr-catheter-clamp-recall-unsealed-packaging-risk. Based on FDA recall #Z-2006-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2006-2018%22&limit=1).

Why it’s dangerous

The unsealed packaging could allow contaminants to enter the sterile product, potentially causing infections during medical procedures. This is a serious hazard because catheter clamps are used in critical medical applications where sterility is essential.

Who’s affected

Healthcare professionals and patients using the catheter clamps in medical settings. Those with the specific lot numbers listed are most at risk.

How to tell if you have this one

Check for the Product Code CC-00004 on the clamp. Affected units include lot numbers 13F17A0199, 13F17C0048, 13F17D0270, 13F17F0258, and 13F17G0529.

  • Brand
    Arrow
  • Category
    Medical device
FDA recall event · 76 products

All 76 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM
Recall numberProduct, codes & lotsQuantity
Z-1957-2018Catheter Hemostasis Valve For use with .038" (.096 cm) dia. and smaller guide wires; Product Code: AI-07000; Lot Numbers: 13F17C0232 13F17G0194 13F17H0047 13F17J0083416,055 total products
Z-1958-2018Continuous Nerve Block Needle; Product Codes: AB-00090, AB-00150, AB-17040-N, AB-17080-N, AB-17110-N, AB-17140-N, AB-18080-N, AB-18110-N; Lot Numbers: 13F17G0253 13F17A0200 13F17F0505 13F17G0256 13F17J0455 13F17C0193 13F17K0105 13F17C0198 13F17J0280 13F17A0063 13F17A0061 13F17B0252 13F17F0190 13F17L0701 13F17A0064 13F17C0225 13F17D0342 13F17J0229 13F17K0592 13F17M0002 13F17A0201 13F17D0246416, 055 total products
Z-1959-2018Echogenic Introducer Needle; Product Code: AN-04318; Lot Numbers: 13F17A0231 13F17B0321 13F17C0241 13F17D0233 13F17E0301 13F17E0725 13F17F0603 13F17G0193 13F17J0089 13F17K0232 13F17L0230 13F17L0231 13F17L0232 13F17L0233416,055 total products
Z-1960-2018Spring Wire Guide Introducer Needle; Product Codes: AN-04320 and AN-04418; Lot Numbers: Product code AN-04320: 13F17A0131,13F17B0101,13F17B0320,13F17D0234, 13F17F0242,13F17H0488,13F17J0454,13F17M0003 Product code AN-04418: 13F17F0738 and 13F17J0445416,055 total products
Z-1961-2018Epidural Needle; Product Codes: AN-05501 and AN-05505; Lot Numbers: Product code AN-05501: 13F17A0211 13F17B0082 13F17C0378 13F17D0082 13F17E0023 13F17E0329 13F17E0838 13F17F0432 13F17F0813 13F17G0333 13F17H0059 13F17J0002 13F17L0598 Product code AN-05505: 13F17A0213 13F17C0109 13F17C0479 13F17E0208 13F17F0254 13F17F0727 13F17G0357 13F17J0161 13F17J0274 13F17L0441416,055 total products
Z-1962-2018SnapLock" Catheter/Syringe Adapter; Product Code: AS-05500; Lot Numbers: 13F17A0065 13F17B0190 13F17D0264 13F17F0246 13F17F0653 13F17J0082 13F17K0412416,055 total products
Z-1963-2018Maximal Barrier Drape; Product Codes: ASK-00001-1A; Lot Numbers: 13F17E0104 13F17F0318 13F17G0569 13F17J0423 13F17L0130416,055 total products
Z-1964-2018Maximal Barrier Drape; Product Codes: ASK-00002-1A; Lot Numbers: 13F17A0212 13F17D0025 13F17D0154 13F17E0193 13F17F0352 13F17G0102 13F17G0102 13F17G0347 13F17H0347 13F17K0324 13F17K0377 13F17L0462416,055 total products
Z-1965-2018Maximal Barrier Drape; Product Codes: ASK-00376-SU; Lot Numbers: 13F17B0089 13F17L0152416,055 total products
Z-1966-2018Maximal Barrier Drape; Product Code: ASK-01000-UPMS; Lot Numbers: 13F17A0280 13F17H0434 13F17L0480416,055 total products
Z-1967-2018Maximal Barrier Drape; Product Code: ASK-04000-HMC; Lot Numbers: 13F17A0216 13F17D0073 13F17F0163 13F17G0522 13F17H0487 13F17L0121 13F17L0651416,055 total products
Z-1968-2018Radial Arterial Access Kit; Product Code: ASK-04001-BID2; Lot Numbers: 13F17A0195 13F17D0213 13F17F0428 13F17K0314 13F17L0113416,055 total products
Z-1969-2018Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-04018-OH1; Lot Numbers: 13F17E0562 13F17G0537 13F17K0188 13F17L0167416,055 total products
Z-1970-2018Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1; Lot Numbers: Product code ASK-04020-AH: 13F17B0102 13F17C0283 13F17F0221 13F17G0480 13F17J0045 13F17L0127 Product code ASK-04020-MIHS: 13F17A0174 13F17F0139 Product code ASK-04120-HF1: 13F17C0360 13F17D0034 13F17E0093 13F17F0468 13F17G0269 13F17J0101 13F17K0311 13F17L0489416,055 total products
Z-1971-2018Arterial Catheterization Kit; Product Codes: ASK-04020-DH; Lot Numbers: 13F17B0307 13F17D0070 13F17E0417 13F17G0012 13F17G0508 13F17H0421 13F17L0155 13F17L0478416,055 total products
Z-1972-2018Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04020-RIHM; Lot Numbers: 13F17C0179 13F17E0655 13F17G0301 13F17H0284 13F17K0566 13F17M0019416,055 total products
Z-1973-2018Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04120-HF; Lot Numbers: 13F17C0281 13F17G0398416,055 total products
Z-1974-2018Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Codes: ASK-04301-TJ; Lot Numbers: 13F17E0674 13F17G0265 13F17J0087 13F17K0099 13F17L0250416,055 total products
Z-1975-2018Arrow-Flex(R) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath and Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters ; Product Codes: ASK-09903-UM; Lot Numbers: 13F17A0258 13F17D0075 13F17G0275 13F17L0615416,055 total products
Z-1976-2018Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters; Product Code: ASK-09903-UPA; Lot Numbers: 13F17E0762 13F17F0599 13F17H0058 13F17J0241 13F17L0114 13F17L0485416,055 total products
Z-1977-2018Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port and Sharps Safety Features (Recommended for use with 7 Fr. Catheters); Product Code: ASK-09907-SB; Lot Numbers: 13F17D0180 13F17H0192 13F17K0223 13F17K0555416,055 total products
Z-1978-2018Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Code: ASK-15402-HOP; Lot Numbers: 13F17C0183 13F17F0775416,055 total products
Z-1979-2018Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-15703-LDP1; Lot Numbers: 13F17B0389 13F17E0430 13F17F0580 13F17H0545 13F17K0403 13F17L0285416,055 total products
Z-1980-2018Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PHMC; Lot Numbers: 13F17A0285 13F17C0381 13F17D0214 13F17E0356 13F17F0736 13F17H0483416,055 total products
Z-1981-2018Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PVH and ASK-15703-PNYP; Lot Numbers: ASK-15703-PVH: 13F17D0024 13F17E0454 13F17G0083 13F17H0048 13F17J0096 13F17K0195 13F17L0138 13F17L0679 ASK-15703-PNYP: 13F17H0123416,055 total products
Z-1982-2018ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7-7.5 Fr. Catheters; Product Code: ASK-21142-WHC2; Lot Numbers: 13F17E0597 13F17F0395 13F17K0120 13F17L0532416,055 total products
Z-1983-2018MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve and Sharps Safety Features for use with 7.5 - 8 Fr. Catheters; Product Code: ASK-21242-NYP and ASK-21242-PR; Lot Numbers: Product code ASK-21242-NYP: 13F17A0076 13F17B0076 13F17B0225 13F17E0773 13F17H0129 13F17J0020 13F17J0395 13F17L0012 Product code ASK-21242-PR: 13F17B0260 13F17F0591 13F17L0010 13F17L0273 13F17M0136416,055 total products
Z-1984-2018Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter and Sharps Safety Features; Product Code: ASK-24306-VC; Lot Numbers: 13F17D0267 13F17F0310 13F17H0326 13F17K0315416,055 total products
Z-1985-2018ARROWg+ard Blue(R) Central Venous Catheterization Kit; Product Code: ASK-24306-WHC1 and ASK-24306-WHC2; Lot Numbers: 13F17B0024 13F17E0019 13F17E0673 13F17J0236 13F17L0497 13F17E0019 13F17E0673 13F17J0236 13F17L0497416,055 total products
Z-1986-2018Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters; Product Codes: ASK-29803-SJH, ASK-29903-SJH, and ASK-29903-UW1; Lot Numbers: Product Codes ASK-29803-SJH: 13F17A0276 13F17D0104 13F17F0165 13F17G0452 13F17H0251 13F17K0284 13F17L0363 Product code ASK-29903-SJH: 13F17C0105 13F17E0803 13F17G0422 13F17H0161 13F17H0204 13F17K0193 13F17M0197 Product code ASK-29903-UW1: 13F16L0231 13F17F0691416,055 total products
Z-1987-2018Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42703-MHW and ASK-42703-OLL1; Lot Numbers: Product Codes ASK-42703-MHW: 13F16M0282 13F17D0183 13F17H0260 13F17M0344 Product Code ASK-42703-OLL1: 13F17C0293 13F17E0414 13F17J0243416,055 total products
Z-1988-2018Pressure Injectable ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Codes: ASK-42703-PAM1, ASK-42703-PSHR1, ASK-45703-PNY, ASK-45703-PWHC1; Lot Numbers: Product Code ASK-42703-PAM1: 13F17K0077 13F17L0494 Product code ASK-42703-PSHR1: 13F17C0361 13F17F0207 13F17H0518 13F17M0278 Product code ASK-45703-PNY: 13F17H0124 13F17H0451 Product code ASK-45703-PWHC1: 13F17E0022416,055 total products
Z-1989-2018ARROWg+ard Blue PLUS¿ Pressure Injectable Quad-Lumen CVC Kit; Product Codes: CDC-42854-P1A and CDC-45854-P1A; Lot numbers: Product code CDC-42854-P1A: 13F17C0137 13F17E0177 13F17E0598 13F17F0644 13F17G0287 13F17H0118 13F17K0156 13F17L0017 13F17M0158 Product code CDC-45854-P1A: 13F17C0396 13F17C0439 13F17D0062 13F17D0284 13F17E0618 13F17F0126 13F17G0293 13F17H0263 13F17J0055 13F17K0168 13F17L0021 13F17L0353 13F17L0590416,055 total products
Z-1990-2018Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Code: ASK-45802-PHMW; Lot Numbers: 13F17E0141 13F17E0300 13F17H0147 13F17J0336416,055 total products
Z-1991-2018Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-45854-PSFM and ASK-42854-PRR; Lot Numbers: Product Code ASK-45854-PSFM: 13F17C0072 13F17E0166 13F17H0261 13F17J0339 13F17L0020 13F17L0401 Product Code ASK-42854-PRR: 13F17B0034 13F17B0278 13F17E0800 13F17H0142 13F17K0160416,055 total products
Z-1992-2018ARROWg+ard Blue PLUS¿ Pressure Injectable Two-Lumen CVC Kit; Product Code: CDC-42802-P1A; Lot Numbers: 13F17B0333 13F17C0338 13F17D0322 13F17E0539 13F17E0870 13F17F0116 13F17H0136 13F17J0024 13F17K0268 13F17L0062 13F17L0207 13F17L0397416,055 total products
Z-1993-2018Pressure Injectable ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit; Product Code: ASK-42802-PWHC1; Lot Numbers: 13F17D0321 13F17H0137 13F17L0063 13F17L0555416,055 total products
Z-1994-2018ARROWg+ard Blue PLUS¿ Pressure Injectable Multi-Lumen CVC Kit; Product Codes: CDC-45703-P1A; CDC-45703-PB1A; CDC-42703-P1A; and CDC-15703-P1A; Lot Numbers: Product Code CDC-45703-P1A: 13F17J0061 13F17J0084 13F17J0451 13F17K0249 13F17K0250 13F17K0383 13F17K0575 13F17L0576 13F17M0154 Product code CDC-45703-PB1A: 13F17B0350 13F17E0048 13F17E0719 13F17H0308 13F17L0099 Product code CDC-42703-P1A: 13F16M0232 13F17J0065 13F17J0450 13F17K0069 13F17K0136 13F17K0288 13F17K0419 13F17K0567 13F17L0223 13F17L0573 Product code CDC-15703-P1A: 13F17A0025 13F17E0279 13F17E0457 13F17F0160 13F17F0769 13F17G0349 13F17J0133 13F17J0134 13F17L0103 13F17M0200416,055 total products
Z-1995-2018Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip¿, ARROWg+ard Blue PLUS¿ Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Codes: ASK-45703-LDP1, ASK-45703-PBHS, ASK-45703-PHMC; Lot Numbers: Product Codes ASK-45703-LDP1: 13F17G0033 Product code ASK-45703-PBHS: 13F16M0260 13F17C0150 13F17E0406 13F17G0421 13F17H0420 13F17L0522 Product code ASK-45703-PHMC: 13F17A0047 13F17B0011 13F17H0012 13F17L0421416,055 total products
Z-1996-2018Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42703-PHCH; Lot Numbers: 13F17B0408 13F17E0421 13F17L0288416,055 total products
Z-1997-2018Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42703-PTJH and ASK-45703-PTJH; Lot Numbers: Product Code ASK-42703-PTJH: 13F17A0168 13F17C0074 13F17D0339 13F17G0029 13F17G0453 13F17L0509 Product code ASK-45703-PTJH: 13F17B0016 13F17C0089 13F17D0105 13F17F0062 13F17H0250 13F17K0220 13F17L0560416,055 total products
Z-1998-2018Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42703-RV1; Lot Numbers: 13F17B0020 13F17B0269 13F17C0303 13F17F0317 13F17H0062 13F17J0386 13F17K0583 13F17L0455416,055 total products
Z-1999-2018Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42703-RV1; Lot Numbers: 13F17B0020 13F17B0269 13F17C0303 13F17F0317 13F17H0062 13F17J0386 13F17K0583 13F17L0455416,055 total products
Z-2000-2018ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-42703-SJH; Lot Numbers: 13F17E0547 13F17F0680 13F17G0214 13F17J0347 13F17L0150416,055 total products
Z-2001-2018Double-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42802-VC and ASK-47702-VC; Lot Numbers: Product Code ASK-42802-VC: 13F17B0388 13F17E0134 13F17H0132 13F17K0152 Product code ASK-47702-VC: 13F17E0669 13F17H0311 13F17L0076416,055 total products
Z-2002-2018Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42802-DMC; Lot Numbers: 13F17C0063 13F17F0665 13F17H0388416,055 total products
Z-2003-2018Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product code: ASK-45703-AEH; Lot Numbers: 13F17E0712 13F17H0264 13F17K0086 13F17K0547 13F17L0647416,055 total products
Z-2004-2018Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions; Product Codes: ASK-45703-SCH; ASK-45703-UAB, ASK-45703-VAH; Lot Numbers: Product Code ASK-45703-SCH: 13F17B0193 13F17E0461 13F17G0450 Product Code ASK-45703-UAB: 13F17C0210 Product Code ASK-45703-VAH: 13F16M0294 13F17E0398 13F17H0074416,055 total products
Z-2005-2018ARROWgard Blue PLUS Triple-Lumen CVC Kit with Blue FlexTip Catheter; Product Code: ASK-45703-VC; Lot Numbers: 13F17A0219 13F17C0013 13F17C0431 13F17D0166 13F17F0070 13F17F0714 13F17G0590 13F17J0392 13F17L0070416,055 total products
Z-2006-20184Fr. Catheter Clamp with Fastener; Product Code: CC-00004; Lot Numbers: 13F17A0199 13F17C0048 13F17D0270 13F17F0258 13F17G0529416,055 total products
Z-2007-20185Fr. Catheter Clamp with Fastener; Product Code: CC-00005; Lot Numbers: 13F17A0198 13F17C0056 13F17D0135 13F17D0236 13F17F0075 13F17F0600 13F17G0179 13F17H0107 13F17H0367 13F17J0198 13F17K0212416,055 total products
Z-2008-20187Fr. Catheter Clamp with Fastener; Product Code: CC-00007; Lot Numbers: 13F17B0257 13F17D0260 13F17E0342 13F17F0076 13F17F0795 13F17J0271416,055 total products
Z-2009-20188Fr. Catheter Clamp with Fastener; Product Code: CC-00008; Lot Numbers: 13F17B0050 13F17D0271 13F17F0078 13F17J0276416,055 total products
Z-2010-2018Clear Fenestrated Drape with Adhesive; Product Code: CD-00001; Lot Numbers: 13F17G0258 13F17J0281416,055 total products
Z-2011-2018Spring-Wire Guide Introducer Catheter Assembly; Product Code: CN-04018; Lot Numbers: 13F17B0039 13F17C0181 13F17D0226 13F17E0065 13F17E0724 13F17F0651 13F17G0531 13F17H0377 13F17J0273 13F17L0216 13F17L0218416,055 total products
Z-2012-2018TheraCath(R) Epidural Catheter; Product Code: EC-05000; Lot Numbers: 13F17B0147 13F17C0176 13F17C0419 13F17E0464 13F17F0039 13F17F0498 13F17F0609 13F17F0789 13F17G0250 13F17J0076 13F17K0413 13F17K0414 13F17K0415 13F17K0416416,055 total products
Z-2013-20180.2 Micron Flat Epidural Filter; Product Code: EF-05500; Lot Numbers: 13F17D0240 13F17G0371 13F17K0408416,055 total products
Z-2014-2018Arrow-Johans" ECG Adapter for Right Atrial Electrocadiography (RAECG); Product Code: EG-04900; Lot Numbers: 13F17C0326 13F17E0123 13F17F0584 13F17G0519 13F17H0292416,055 total products
Z-2015-2018ARROW JACC with Chlorag+ard Technology; Product Code: JR-42063-HPHNM and JR-42563-HPHNM; Lot Numbers: Product code JR-42063-HPHNM: 13F17C0327 Product code JR-42563-HPHNM: 13F17F0099416,055 total products
Z-2016-201810 cc Luer-Slip Loss of Resistance Syringe; Product Code: LR-05501; Lot Numbers: 13F17C0328 13F17F0296 13F17G0202 13F17H0104 13F17J0207416,055 total products
Z-2017-2018Percutaneous Sheath Introducer Kit with ARROWgard Blue¿ Sheath and Integral Hemostasis Valve/Side Port for use with 7 - 7.5 Fr. Catheters; Product Codes: MSO-29802-AHS and MSO-29903-AHS; Lot Numbers: Product Code MSO-29802-AHS: 13F17C0408 13F17E0419 13F17F0683 13F17H0283 13F17K0545 Product Code MSO-29903-AHS: 13F17E0607 13F17G0356 13F17K0327 13F17L0350416,055 total products
Z-2018-2018ARROWgard Blue PLUS¿ Multi-Lumen CVC Kit with Blue FlexTip¿ Catheter; Product Code: MSO-45703-AHS; Lot Numbers: 13F17C0230 13F17D0161 13F17F0068 13F17G0364 13F17H0351 13F17J0387 13F17K0579 13F17L0487416,055 total products
Z-2019-2018Arterial Catheterization Kit; Product Code:NA-04550-1A; Lot Numbers: 13F17B0315 13F17C0033 13F17C0462 13F17F0145 13F17F0550 13F17G0229 13F17H0049 13F17H0328416,055 total products
Z-2020-2018PICC Catheter Trimmer ; Product Code:PC-00001-T; Lot Numbers: 13F17C0349 13F17F0300416,055 total products
Z-2021-2018Peel Away Sheath over Dilator; Product Codes: PL-05041 and PL-05052; Lot Numbers: Product Code: PL-05041 13F17G0050 13F17J0360 13F17K0376 Product Code and PL-05052: 13F17C0435 13F17E0720 13F17G0077 13F17G0514416,055 total products
Z-2022-2018Echogenic Needle; Product codes: PN-00215-E and PN-00217-E; Lot Numbers: Product Codes PN-00215-E: 13F17J0072 13F17K0211 13F17L0700 Product code PN-00217-E: 13F17C0329 13F17E0118 13F17F0503 13F17G0093 13F17G0534 13F17H0383 13F17L0234416,055 total products
Z-2023-2018ARROW PICC Set; Product codes: PR-34052-HPHNM, PR-34063-HPHNM, PR-35041-HPHNM, PR-35052-HPHNM, PR-35541-HPHNL, PR-35541-HPHNM, PR-35552-HPHNL, PR-35552-HPHNM; Lot Numbers: Product Code PR-34052-HPHNM: 13F17C0351 Product Code PR-34063-HPHNM: 13F17F0192 Product Code PR-35041-HPHNM: 13F17B0290 13F17C0231 13F17D0238 13F17F0276 13F17F0577 13F17H0365 13F17J0409 13F17K0490 13F17L0394 13F17L0395 Product Code PR-35052-HPHNM: 13F17B0092 13F17B0256 13F17C0043 13F17D0094 13F17D0239 13F17E0224 13F17F0586 13F17H0354 13F17J0196 13F17K0549 13F17L0474 13F17L0697 13F17M0121 Product Code PR-35541-HPHNL: 13F17F0219 13F17H0523 Product Code PR-35541-HPHNM: 13F17A0110 13F17B0046 13F17B0161 13F17C0353 13F17F0652 Product Code PR-35552-HPHNL: 13F17B0322 13F17J0008 Product Code PR-35552-HPHNM: 13F17B0109 13F17B0318 13F17F0245416,055 total products
Z-2024-2018ARROW PICC Set; Product codes: PR-35563-HPHNL and PR-35563-HPHNM; Lot Numbers: Product Code PR-35563-HPHNL: 13F17F0445 Product Code PR-35563-HPHNM: 13F17K0495416,055 total products
Z-2025-2018Arrow PICC with Chlorag+ard Technology; Product codes: PR-44041-BAS, PR-44052-BAS, PR-44063-BAS, PR-45041-BAS, PR-45052-BAS, PR-45063-BAS, PR-45541-BAS,PR-45541-HPHNL, PR-45541-HPHNM, PR-45552-BAS, PR-45552-HPHNL,PR-45552-HPHNM, PR-45563-BAS, PR-45563-HPHNL, PR-45563-HPHNM; Lot Numbers: Product code: PR-44041-BAS: 13F17F0101 PR-44052-BAS: 13F17F0103 13F17K0128 PR-44063-BAS: 13F17F0104 13F17K0129 PR-45041-BAS: 13F17F0105 13F17K0241 PR-45052-BAS: 13F17F0106 13F17K0236 PR-45063-BAS: 13F17J0203 13F17K0471 PR-45541-BAS: 13F17F0107 PR-45541-HPHNL: 13F17A0165 13F17D0327 13F17G0008 13F17H0416 13F17H0572 13F17K0238 13F17L0049 PR-45541-HPHNM: 13F17B0174 13F17C0188 13F17E0738 13F17G0006 PR-45552-BAS: 13F17F0108 13F17K0237 PR-45552-HPHNL: 13F17C0467 13F17E0017 13F17E0758 13F17F0523 PR-45552-HPHNM: 13F17B0178 13F17C0469 13F17E0120 13F17G0412 13F17H0393 13F17J0172 13F17L0335 PR-45563-BAS: 13F17F0109 PR-45563-HPHNL: 13F17C0354 13F17D0341 13F17J0402 PR-45563-HPHNM: 13F17L0688416,055 total products
Z-2026-2018VPS Rhythm ECG Accessory Pack with Johans Adapter; Product codes: RHY-100-ECGJ; Lot Numbers: 13F17A0120 13F17A0287 13F17C0018 13F17D0136 13F17E0122416,055 total products
Z-2027-2018VPS Rhythm ECG Accessory Pack ; Product codes: RHY-100-ECGO; Lot Numbers: 13F17A0288416,055 total products
Z-2028-2018VPS TipTracker Stylet Accessory; Product codes: RHY-177-TTSAP; Lot Numbers: 13F17A0119 13F17D0019 13F17D0130 13F17D0186 13F17D0278 13F17E0113 13F17F0193 13F17F0480 13F17G0074 13F17G0329 13F17G0506 13F17H0536 13F17J0208 13F17K0438416,055 total products
Z-2029-2018Sheath Adapter with Cath-Gard¿ Catheter Contamination Shield for use with 4 - 7 Fr. Catheters; Product codes: SA-09847; Lot Numbers: 13F17B0051 13F17E0713 13F17F0767 13F17J0010416,055 total products
Z-2030-2018Extension Line Slide Clamps; Product codes: SA-09847; Lot Numbers: 13F17A0109 13F17D0071 13F17E0795 13F17F0743 13F17H0099 13F17K0227416,055 total products
Z-2031-2018ARROWg+ard Blue¿ PSI Kit with Integral Hemostasis Valve/ Side Port for use with 7 - 7.5 Fr. Catheters; Product codes: SF-29803-1; Lot Numbers: 13F17C0004 13F17G0030416,055 total products
Z-2032-20189 Fr. Radiopaque Polyurethane Sheath/Dilator with Integral Hemostasis Valve/Side Port for use with 7 - 8 Fr. Catheters and Arrow Percutaneous Introducer System; Product codes: SS-09903-S; Lot Numbers: 13F17H0405416,055 total products
Based on the official FDA remedy

What to do — step by step

  1. Stop Using It Now

    Immediately stop using the recalled catheter clamps as the unsealed packaging may compromise sterility.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFLPuerto Rico: yesPR

FDA distribution: “US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 2.1 years after the firm started it.

1. Firm started the recall: Apr 11, 201812. FDA classified it Class II: May 30, 201823. Published in FDA’s Enforcement Report: Jun 6, 201834. FDA terminated the recall: May 15, 2020420182020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2006-2018 (April 11, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2006-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA