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Lower risk Medical device recall · FDA · Published March 1, 2024

Cook Peel-Away Introducer Recall: Packaging May Compromise Sterility

Cook recalls Peel-Away Introdu: Packaging may have low seal strength, risking device sterility. Affected units sold with specific part numbers. Stop using immediately if you own the recalled model.

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

🇺🇸 FDA recall #Z-1528-2024Medical deviceCook ›
Take action

Contact the company

Recalling firmCook Incorporated750 N Daniels Way · Bloomington, IN 47404-9120
✎ GovInfoNow plain-language explainer

Cook is recalling Peel-Away Introducers due to packaging that may not seal properly, which could compromise the device's sterility. This means the medical device might not be clean enough for safe use, potentially causing infections. Read more at govinfonow.com/recall/56011-cook-peel-away-introducer-recall-packaging-may-compromise-sterility.

Source Summary by GovInfoNow · govinfonow.com/recall/56011-cook-peel-away-introducer-recall-packaging-may-compromise-sterility · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1528-2024

Cite this page

“Cook Peel-Away Introducer Recall: Packaging May Compromise Sterility.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56011-cook-peel-away-introducer-recall-packaging-may-compromise-sterility. Based on FDA recall #Z-1528-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1528-2024%22&limit=1).

The FDA announced on March 1, 2024, that Cook Incorporated is recalling Peel-Away Introducers because low seal strength may compromise device sterility. The agency issued recall number Z-1528-2024 for the Class II device.

How to tell if you have it

  • Peel-Away Introducer
  • UPC 00827002009257
  • UPC 00827002018440

The hazard

According to the FDA, packaging may have low seal strength and not meet peel strength specifications, compromising device sterility.

Context

GovInfoNow's records show Cook Incorporated has 15 other recalls on record since May 5, 2022. Recent Cook recalls include Beacon Tip Centimeter Sizing Catheters (April 2, 2026), Approach CTO-6 Micro Wire Guide (March 5, 2026), and Flexor Check-Flo Introducers and Sets (Nov. 26, 2025). Other recent recalls of similar products include Medline Quick-Strip Bandages Recall (Oct. 27, 2025) and Medline Convenience Kits Recall (June 12, 2026).

How to tell if you have this one

Check for part numbers PLVW-7.0-35 (G00925) or PLVW-8.0-35 (G01844) on the packaging. The recall covers units sold with these specific part numbers.

  • Brand
    Cook
  • Product
    Peel-Away Introducer
  • Category
    Medical device
FDA recall event · 8 products

All 8 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
    Ongoing
  • Distribution
    Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
Recall numberProduct, codes & lotsQuantity
Z-1525-2024Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN): 1) DCHN-18-10.0 G01559 2) DCHN-18-10.0-U G05040 3) DCHN-18-15.0 G00850 4) DCHN-22-10.0 G00852 5) DCHN-22-10.0-U G03978 6) DCHN-22-15.0 G00012 7) DCHN-22-15.0-U G03314 8) DCHN-22-20.0 G00013 9) DCHN-22-20.0-U G04338; RPN/UDI/Lot Numbers 1) DCHN-18-10.0 (01)00827002015593(17) 15787141, 15787142, 15787693, 15794668, 15794669, 15794728, 15797998 2) DCHN-18-10.0-U (01)00827002050402(17) NS15781793, NS15781794, NS15783895 NS15783896, NS15783899, NS15783900, NS15784336, NS1580853,5 NS15808536, NS15808537 3) DCHN-18-15.0 (01)00827002008502(17) 15595244 4) DCHN-22-10.0 (01)00827002008526(17) 15628472 5) DCHN-22-10.0-U (01)00827002039780(17) 15614507 6) DCHN-22-15.0 (01)00827002000124(17) 15628470, 15785990,15791249 15794719 7) DCHN-22-15.0-U (01)00827002033146(17)15784638, 15784722,15784724, 15795935, 15797991, 15797992 8) DCHN-22-20.0 (01)00827002000131(17) 15629865 9) DCHN-22-20.0-U (01)00827002043381(17) NS158085476,178 units
Z-1526-2024Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal system REFERENCE PART NUMBER (RPN): DTN-18-20.0 ORDER NUMBER (GPN): G01377; UDI: (01)00827002013773(17) Lot Number: 1578658855 units
Z-1527-2024Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or thoracentesis. REFERENCE PART NUMBER (RPN): DTVN-5.0-19-10.0- YUEH ORDER NUMBER (GPN): G09490; UDI: (01)00827002094901(17) Lot Number: 15787864, 15804398296 units
Z-1528-2024Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into central and peripheral vasculature, and for nonvascular use. REFERENCE PART NUMBER (RPN)/ ORDER NUMBER (GPN): 1)PLVW-7.0-35 G00925 2)PLVW-8.0-35 G01844 : DTVN-5.0-19-10.0- YUEH : G09490; UDI-DI/Lot Number: 1) (01)00827002009257(17) 15777767 2) (01)00827002018440(17) NS1578753255 units
Z-1529-2024Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters. REFERENCE PART NUMBER (RPN): GIAS-SRM-ADJ-2 ORDER NUMBER (GPN): G35562; UDI-DI: (01)00827002355620(17) Lot Number: 157919068 units
Z-1530-2024Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. 1) JCD10.0-38-20 2) JCD20.0-38-20 3) JCD22.0-38-20 4) JCD6.0-38-15 5) JCD8.0-38-15 6) JCD8.0-38-20; 1)JCD10.0-38-20 (01)00827002009936(17) Lot Numbers: 15794371, 15794373, 15794374, 15806068, 15816198, 15816199 15816200 2) JCD20.0-38-20 (01)00827002014718(17) Lot Numbers: 15784153, 15784159, 15784160, 15794192, 15794199, 15794202. 15804028 3) JCD22.0-38-20 (01)00827002014725(17) Lot Numbers: 15794207, 15806062 4) JCD6.0-38-15 (01)00827002009448(17) Lot Number: 15814407 5) JCD8.0-38-15 (01)00827002009998(17) Lot Numbers: 15797971, 15797979 6) JCD8.0-38-20 (01)00827002009806(17) Lot Number:157910735,998 units
Z-1531-2024Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. REFERENCE PART NUMBER (RPN)/ORDER NUMBER (GPN): 1) JCD10.0-38-20-HC G10207 2) JCD14.0-38-20-HC G10293 3) JCD16.0-38-20-HC G10206 4) JCD6.0-38-20-HC G10285 5) JCD8.0-38-20-HC G10289; Ref. Number/UDI-DI/Lot Numbers: 1) JCD10.0-38-20-HC (01)00827002102071(17) 15794369 2) JCD14.0-38-20-HC (01)00827002102934(17) 15778297, 15787264 3) JCD16.0-38-20-HC (01)00827002102064(17) 15794375 4)JCD6.0-38-20-HC (01)00827002102859(17) NS15808469 5) JCD8.0-38-20-HC (01)00827002102897(17) 157612591,493 units
Z-1532-2024Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. REFERENCE PART NUMBER (RPN)/ORDER NUMBER (GPN): 1) JCD10.0-38-20- COONS G03928 2) JCD12.0-38-20- COONS G03929 3) JCD14.0-38-20- COONS G03932 4) JCD16.0-38-20- COONS G03947 5) JCD18.0-38-20- COONS G04051 6) JCD20.0-38-20- COONS G04264 7) JCD22.0-38-20- COONS G04443 8) JCD6.0-38-20- COONS G04221 9) JCD8.0-38-20- COONS G03927; Ref. Number/UDI-DI/Lot Numbers: 1) JCD10.0-38-20- COONS (01)00827002039285(17) 15787236; 2) JCD12.0-38-20- COONS (01)00827002039292(17) 15774752, 15774753; 3) JCD14.0-38-20- COONS (01)00827002039322(17) 15797981, 15784149, 15797975 15797976, 15797982; 4) JCD16.0-38-20- COONS (01)00827002039476(17) 15794190, 15794191, 15808405; 5) JCD18.0-38-20- COONS (01)00827002040519(17) 15794189, 15797973; 6) JCD20.0-38-20- COONS (01)00827002042643(17) 15784152, 15784156, 15784158 15784164, 15794195, 15804033; 7) JCD 38-20- COONS (01)00827002044432(17) 15767086, 15784163, 15794203, 15806060; 8) JCD6.0-38-20- COONS (01)00827002042216(17) 15787237, 15787244 9) JCD8.0-38-20- COONS (01)00827002039278(17) 15797985, 15797999, 157980034,856 units
Based on the official FDA remedy

What to do — step by step

  1. Check Packaging

    Look for part numbers PLVW-7.0-35 (G00925) or PLVW-8.0-35 (G01844) on the packaging to identify affected units.

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: yesFL

FDA distribution: “Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.” 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 published this recall 54 days after the firm started it.

1. Firm started the recall: Mar 1, 202412. FDA classified it Class II: Apr 12, 202423. Published in FDA’s Enforcement Report: Apr 24, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

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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-1528-2024 (March 1, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1528-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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