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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.: Medical Convenience Kits Recalled Due to Sterilization Assurance Failure

Agency Publication Date: September 24, 2024
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Summary

American Contract Systems, Inc. is recalling 1,631 units of various medical convenience kits, including Pacemaker, Endovascular, and Arthroscopy packs, because a malfunctioning chart recorder caused humidity levels to fall outside of required safety specifications during processing. This failure means the company cannot guarantee that the surgical tools and medical supplies inside these kits were properly sterilized. Using unsterile medical equipment can lead to serious post-operative infections or other health complications for patients. These kits were distributed to healthcare facilities in Missouri, Minnesota, Massachusetts, Ohio, and Nebraska.

Risk

The lack of confirmed sterilization means the medical devices may carry bacteria or other pathogens directly into sterile surgical sites or bloodstream, posing a significant risk of infection to patients undergoing invasive procedures.

What You Should Do

  1. Identify if you have any of the affected medical convenience kits by checking the product name, UDI-DI, and Lot number on the packaging. Affected products include PACEMAKER PACK (UDI-DI: 00191072213846, Lot: 2405112), Endovascular AAA Pack (UDI-DI: 00191072218339, Lot: 2405153), and Arthroscopy Pack (UDI-DI: 00191072200938, Lot: 2405153).
  2. Check additional affected lots: Endovascular AAA Pack (Lot: 2405152), Open Shoulder (Lot: 2405141), Day Surgery General Pack (Lot: 2405131), Shoulder (Lot: 2405112), Bilateral Tubal Ligation (Lot: 2405102), Paracentesis Thoracente (Lot: 2405102), and IR Procedure Pack (Lot: 2405102).
  3. Verify other specific kits with Lot 2405102: Neuro Vascular, Hand Pack, Vaginal Delivery, Cath Lab Pack, and Essentia MAJ Laparotomy Std Pack. Also check ENT (Lot: 2405092), Nasal Sinus Pack (Lot: 2405093), Cysto (Lot: 2405033), and Pacemaker (Lot: 2405033).
  4. Immediately stop using any kits from the affected lots and quarantine them to prevent use in clinical settings.
  5. Contact your healthcare provider if you have concerns about procedures performed using these packs, or contact American Contract Systems, Inc. at their Kansas City facility for further instructions and potential return or refund details.
  6. For additional questions regarding this recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Quarantine and contact manufacturer

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

Affected Products

Product: PACEMAKER PACK, SLCV01J; Medical convenience kit
Model / REF:
SLCV01J
UPC Codes:
00191072213846
Lot Numbers:
2405112
Date Ranges: 05/11/2025
Product: Endovascular AAA Pack, ESED52B; Medical convenience kit
Model / REF:
ESED52B
UPC Codes:
00191072218339
Lot Numbers:
2405153
Date Ranges: 05/15/2025
Product: Endovascular AAA Pack, ESED52B; Medical convenience kit
Model / REF:
ESED52B
UPC Codes:
00191072198402
Lot Numbers:
2405152
Date Ranges: 05/15/2025
Product: Arthroscopy Pack, MSKA45A; Medical convenience kit
Model / REF:
MSKA45A
UPC Codes:
00191072200938
Lot Numbers:
2405153
Date Ranges: 05/15/2025
Product: Open Shoulder, LWOS39L; Medical convenience kit
Model / REF:
LWOS39L
UPC Codes:
00191072177032
Lot Numbers:
2405141
Date Ranges: 05/14/2025
Product: Day Surgery General Pack, FHGE18T; Medical convenience kit
Model / REF:
FHGE18T
UPC Codes:
00191072210517
Lot Numbers:
2405131
Date Ranges: 05/13/2025
Product: Shoulder, SESH18I; Medical convenience kit
Model / REF:
SESH18I
UPC Codes:
00191072198532
Lot Numbers:
2405112
Date Ranges: 05/11/2025
Product: Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit
Model / REF:
FHBT3T
UPC Codes:
00191072178107
Lot Numbers:
2405102
Date Ranges: 05/10/2025
Product: Paracentesis Thoracente, SLPT76H; Medical convenience kit
Model / REF:
SLPT76H
UPC Codes:
00191072199065
Lot Numbers:
2405102
Date Ranges: 05/10/2025
Product: IR Procedure Pack, CEAT19W; Medical convenience kit
Model / REF:
CEAT19W
UPC Codes:
00191072184566
Lot Numbers:
2405102
Date Ranges: 05/10/2024
Product: Neuro Vascular, ANKV91A; Medical convenience kit
Model / REF:
ANKV91A
UPC Codes:
00191072201232
Lot Numbers:
2405102
Date Ranges: 05/10/2025
Product: Hand Pack, AKHD97C; Medical convenience kit
Model / REF:
AKHD97C
UPC Codes:
00191072217660
Lot Numbers:
2405102
Date Ranges: 05/10/2025
Product: Vaginal Delivery, ASDV25B; Medical convenience kit
Model / REF:
ASDV25B
UPC Codes:
00191072218841
Lot Numbers:
2405102
Date Ranges: 05/10/2025
Product: Cath Lab Pack, CECL02P; Medical convenience kit
Model / REF:
CECL02P
UPC Codes:
00191072206497
Lot Numbers:
2405102
Date Ranges: 05/10/2025
Product: Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kit
Model / REF:
ESLT53B
UPC Codes:
00191072218438
Lot Numbers:
2405102
Date Ranges: 05/10/2025
Product: ENT, COEN27N; Medical convenience kit
Model / REF:
COEN27N
UPC Codes:
00191072206244
Lot Numbers:
2405092
Date Ranges: 05/09/2025
Product: Nasal Sinus Pack, MTSN26B; Medical convenience kit
Model / REF:
MTSN26B
UPC Codes:
00191072200242
Lot Numbers:
2405093
Date Ranges: 05/09/2025
Product: Cysto, FTCY03L; Medical convenience kit
Model / REF:
FTCY03L
UPC Codes:
00191072189295
Lot Numbers:
2405033
Date Ranges: 05/03/2025
Product: Pacemaker, COPM11B; Medical convenience kit
Model / REF:
COPM11B
UPC Codes:
00191072206312
Lot Numbers:
2405033
Date Ranges: 05/03/2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95261
Status: Active
Manufacturer: American Contract Systems, Inc.
Sold By: Direct distribution to healthcare facilities
Manufactured In: United States
Units Affected: 19 products (20 units; 93 units; 360 units; 48 units; 12 units; 280 units; 60 units; 18 units; 504 units; 1 unit; 1 unit; 2 units; 1 unit; 1 unit; 68 units; 66 units; 57 units; 36 units; 3 units)
Distributed To: Missouri, Minnesota, Massachusetts, Ohio, Nebraska

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.