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Lower risk Medical device recall · FDA · Published February 6, 2025

American Contract Systems Vascular Pack Recall: Possible Sterilization Issues

American Contract Systems recalls vascular packs with model numbers UTMV78X-01, UTMV78Y, etc. due to possible sterilization issues that could delay or prolong medical treatment.

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

🇺🇸 FDA recall #Z-1358-2025Medical deviceAmerican Contract Systems ›
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Contact the company

Recalling firmAmerican Contract Systems Inc85 Shaffer Park Dr · Tiffin, OH 44883-9290
✎ GovInfoNow plain-language explainer

American Contract Systems is recalling vascular packs with specific model numbers because they may not have been properly sterilized. This could lead to delays or longer treatment times for patients using these medical devices. Read more at govinfonow.com/recall/52933-american-contract-systems-vascular-pack-recall-possible-sterilization-issues.

Source Summary by GovInfoNow · govinfonow.com/recall/52933-american-contract-systems-vascular-pack-recall-possible-sterilization-issues · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1358-2025

Cite this page

“American Contract Systems Vascular Pack Recall: Possible Sterilization Issues.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52933-american-contract-systems-vascular-pack-recall-possible-sterilization-issues. Based on FDA recall #Z-1358-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1358-2025%22&limit=1).

The FDA announced on Feb. 6, 2025, that American Contract Systems Inc is recalling MAJOR VASCULAR PACK kits due to potential sterilization failures. The agency said the lack of confirmed sterilization assurance may lead to delayed or prolonged treatment for patients.

How to tell if you have it

  • Brand: American Contract Systems
  • Product: MAJOR VASCULAR PACK
  • Model Nos.: UTMV78X-01, UTMV78Y, UTMV78Y-01, UTMV78X-01, UTMV78Y-02
  • Lots: 974241, 884241, 70-051159, 70-052011, 70-052602, 70-053158
  • Quantity: 147 kits

The hazard

American Contract Systems Inc stated it is unable to confirm that product sterilization assurance requirements were met. The agency said this possible loss or lack of functionality may lead to delay or prolonged treatment.

Context

GovInfoNow's records show American Contract Systems Inc has 21 other recalls on record since 2018-11-21. Other recent recalls of similar products include Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ROBOTIC PACK - 242561 (2026-08-10), Convenience Kit Recall: Catheters May Not Meet Performance Specs (2026-06-29), and Medical Kits Recall: Endotoxin Variability Risk (2026-05-19).

How to tell if you have this one

Check for model numbers UTMV78X-01, UTMV78Y, UTMV78Y-01, UTMV78X-01, or UTMV78Y-02 on the pack. The packs were sold with specific lot numbers and UDI-DI codes listed in the recall notice.

  • Brand
    American Contract Systems
  • Category
    Medical device
FDA recall event · 32 products

All 32 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
    US Nationwide distribution in the state of OH.
Recall numberProduct, codes & lotsQuantity
Z-1331-2025LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G; 1. Model No. CALS41F UDI-DI 00191072215727 Tray Lots 962241 70-050280 70-050870 70-051556 2. Model No. CALS41F-01 UDI-DI 00191072215727 Tray Lot 70-052412 3. Model No. CALS41G UDI-DI 00191072233332 Tray Lot 70-053051303 kits
Z-1332-2025DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01; 1. Model No. CCDU12C UDI-DI 00191072196323 Tray Lots 968241 70-050508 70-050945 70-051497 70-051882 2. Model No. CCDU12D UDI-DI 00191072229472 Tray Lot 70-052444 3. Model No. CCDU12D-01 UDI-DI 00191072229472 Tray Lot 70-0529671200 kits
Z-1333-2025HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02; UDI-DI 00191072193483 Lots 962241 914241 70-050890 70-051579 70-052206 70-053085388 kits
Z-1334-2025MAJOR DIEP, Model Nos. CCMJ73G-01 CCMJ73H; UDI-DI 00191072222824 00191072223890 Lots 879241 70-05291517 kits
Z-1335-2025CYSTO PACK , Model N. HKCY31A; UDI-DI 00191072059093 Lots 933241 70-051382 70-05266436 kits
Z-1336-2025C-SECTION PACK, Model Nos LLCS44F LLCS44F-01; UDI-DI 00191072219107 Lots 70-051011 70-051709 70-052452 70-052952252 kits
Z-1337-2025LAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-02; UDI-DI 00191072219206 Lots 882241 70-051163 70-051373 70-051564 70-052582 70-053048630 kits
Z-1338-2025LABOR & DELIVERY PACK, Model Nos LLLD19H; UDI-DI 00191072219213 Lots 885241 70-051324 70-051967 70-052455 70-053006725 kits
Z-1339-2025OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I; UDI-DI 00191072219251 Lots 898241 70-050704 70-05173190 kits
Z-1340-2025GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03; UDI-DI 00191072219510 Lots 70-050850 70-051285 70-051779 70-051779A 70-052186 70-052669 70-053022956 kits
Z-1341-2025BORN ON ARRIVAL KIT , Model No LLBN11B; UDI-DI 00191072219558 Lots 891241 70-051710 70-05235454 kits
Z-1342-2025C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04; UDI-DI 00191072219596 Lots 907241 70-050816 70-051301 70-051839 70-052420 70-052910 70-0531001106 kits
Z-1343-2025CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01; UDI-DI 00191072219602 Lots 70-050707 70-050860 70-051149 70-051713 70-052363 70-0530441420
Z-1344-2025LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02; UDI-DI 00191072219794 Lots 892241 70-051048 70-051516 70-052113 70-052313 70-052401 70-0529111836 kits
Z-1345-2025URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03; UDI-DI 00191072136688 Lots 905241 70-050739 70-051020 70-051480 70-051606 70-05188841 kits
Z-1346-2025CYSTO , Model No SACY80R; UDI-DI 00191072223425 Lots 70-51139 70-052248 70-052564 70-052954144 kits
Z-1347-2025TOTAL HIP PACK , Model No SMTH06O SMTH06P; UDI-DI 00191072163882 00191072229601 Lots 969241 928241 70-051508 70-05251724 kits
Z-1348-2025DELIVERY PACK , Model No SGDV22D-01 SGDV22E; UDI-DI 00191072223685 00191072230164 Lots 70-051227 70-05234736 kits
Z-1349-2025LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B; UDI-DI 00191072135063 00191072223715 Lots 899241 70-050880 70-051697 70-052161 70-052662690 kits
Z-1350-2025LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B; UDI-DI 00191072135063 00191072223715 Lots 899241 70-050880 70-051697 70-052161 70-052662690 kits
Z-1351-2025EAR PACK , Model No SFEA12A; UDI-DI 00191072167446 Lots 968241 888241 70-052114 70-052727 70-05313251 kits
Z-1352-2025LAPAROSCOPY PACK , Model No SFLA02A SFLA02B; UDI-DI 00191072167491 00191072218698 Lots 971241 947241 926241 894241 70-051029 70-051995 70-052417 70-052771237 kits
Z-1353-2025CV BASIC PUMP PACK , Model No WECV23D; UDI-DI 00191072206664 Lots 939241 71-050895 71-051582 71-052213134 kits
Z-1354-2025DIAGNOSTIC NEURO IR TRAY , Model No WENE21; UDI-DI 00191072212900 00191072218001 Lots 960241 71-050727 71-051234 71-051771 71-052322 71-052501 71-052705170 kits
Z-1355-2025NEURO IR TRAY , Model No WENI56J; UDI-DI 00191072217813 Lots 893241 71-051182 71-051813120 kits
Z-1356-2025AV FISTULA , Model No UTAV77T; UDI-DI 00191072205179 Lots 961241 890241 70-051326 70-051979 70-05305890 kits
Z-1357-2025GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08; UDI-DI 00191072147196 Lots 941241 899241 70-050873 70-051230 70-051578 70-052009A 70-052884534 kits
Z-1358-2025MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02; UDI-DI 00191072205100 00191072217370 Lots 974241 884241 70-051159 70-052011 70-052602 70-053158147 kits
Z-1359-2025OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02; UDI-DI 00191072184450 00191072221070 Lots 921241 70-051173 70-05243954 kits
Z-1360-2025SPINE LUMBAR PACK , Model No UTSL72AA UTSL72AB; UDI-DI 00191072179753 Lots 939241 88241 70-052063 70-052618A 70-053157106 kits
Z-1361-2025THORACIC PACK , Model No UTTC82Y UTTC82AA-01; UDI-DI 00191072147332 Lots 954241 921241 889241 70-051283 70-052001 70-052096 70-05323340 kits
Z-1362-2025VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03; UDI-DI 00191072205193 Lots 70-051418 70-052083 70-05285048 kits
Based on the official FDA remedy

What to do — step by step

  1. Check Product Model

    Identify the model number on the vascular pack to see if it matches the recalled models: UTMV78X-01, UTMV78Y, UTMV78Y-01, UTMV78X-01, or UTMV78Y-02.

Where it went and when

Where it was distributed

Distributed nationwide.

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: “US Nationwide distribution in the state of OH.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 48 days after the firm started it.

1. Firm started the recall: Feb 6, 202512. FDA classified it Class II: Mar 14, 202523. Published in FDA’s Enforcement Report: Mar 26, 202532025
  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-1358-2025 (February 6, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1358-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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