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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

American Contract Systems, Inc.: Various Convenience Kits Recalled for Possible Compromised Sterility

Agency Publication Date: August 7, 2024
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Summary

American Contract Systems is recalling approximately 596 surgical and medical convenience kits, including Hand Packs, Laparoscopy, Cataract, and Spine packs, because they were released with insufficient aeration time after sterilization. This manufacturing defect means the kits may not be properly sterile, which can lead to serious infections during medical procedures. These kits were distributed across seven states and are identified by specific lot numbers and expiration dates ranging from early to mid-January 2025. Consumers and healthcare providers should contact the manufacturer immediately for instructions on returning or replacing these products.

Risk

The kits may have been compromised in sterility due to inadequate processing time in the aeration chamber. Using non-sterile medical equipment during surgical or biopsy procedures can introduce pathogens directly into a patient's body, posing a significant risk of infection or other serious health complications.

What You Should Do

  1. Check your medical inventory for American Contract Systems convenience kits with the following lot numbers: 982241 (Hand Pack, Gyn Laparoscopy, Special Procedure), 981241 (Gyn Laparoscopy, Laparoscopy Litho, Special Procedure, Biopsy Drape), 983241 (Extremity), 988241 (Hand Pack, Cataract), 989241 (Total Knee Pack), or 980241 (Spine Pack).
  2. Verify the expiration dates on the packaging; affected units have expiration dates between January 10, 2025, and January 19, 2025.
  3. If you identify an affected kit, stop using it immediately and quarantine the product to ensure it is not used in any medical procedures.
  4. Contact your healthcare provider or American Contract Systems at their Kansas City facility to arrange for the return and replacement of the compromised kits.
  5. For further information or questions regarding this recall, contact the FDA medical device recall line at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action

Healthcare provider or manufacturer contact

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: American Contract Systems Hand Pack convenience kit
UPC Codes:
00191072203717
Lot Numbers:
982241 (Exp. Date 1/18/2025)
Date Ranges: 1/18/2025
Product: American Contract Systems Gyn Laparoscopy convenience kit
Model / REF:
SLGL64K
SMGY46A
UPC Codes:
00191072202017
00191072188458
Lot Numbers:
981241 (Exp. Date 1/19/2025)
982241 (Exp. Date 1/18/2025)
Date Ranges: 1/18/2025, 1/19/2025
Product: American Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract Systems Lap Chole convenience kit
UPC Codes:
00191072190536
Lot Numbers:
981241 (Exp. Date 1/19/2025)
Date Ranges: 1/19/2025
Product: American Contract Systems Special Procedure Pack convenience kit
Model / REF:
SLSP77G
EJAG58A
UPC Codes:
00191072198730
00191072190093
Lot Numbers:
981241 (Exp. Date 1/19/2025)
982241 (Exp. Date 1/18/2025)
Date Ranges: 1/18/2025, 1/19/2025
Product: American Contract Systems Extremity, Hand Pack, and Total Knee Pack convenience kits
Model / REF:
ALEX17A
AKHD97A
CETJ13O
UPC Codes:
00191072201546
00191072201126
00191072202017
Lot Numbers:
983241 (Exp. Date 1/17/2025)
988241 (Exp. Date 1/12/2025)
989241 (Exp. Date 1/11/2025)
Date Ranges: 1/11/2025, 1/12/2025, 1/17/2025
Product: American Contract Systems Cataract Pack convenience kit
UPC Codes:
00191072188762
Lot Numbers:
988241 (Exp. Date 1/12/2025)
Date Ranges: 1/12/2025
Product: American Contract Systems Biopsy Drape Pack convenience kit
UPC Codes:
00191072202246
Lot Numbers:
981241 (Exp. Date 1/19/2025)
Date Ranges: 1/19/2025
Product: American Contract Systems Spine Pack convenience kit
UPC Codes:
00191072202499
Lot Numbers:
980241 (Exp. Date 1/10/2025)
Date Ranges: 1/10/2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94908
Status: Active
Manufacturer: American Contract Systems, Inc.
Sold By: Direct distribution to healthcare facilities
Manufactured In: United States
Units Affected: 8 products (90; 29 kits; 120; 112; 15 kits; 3; 224; 3)
Distributed To: California, Kansas, Maine, Minnesota, Missouri, Nebraska, South Dakota

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.