American Contract Systems, Inc.: Various Surgical Kits and Trays Recalled Due to Sterilization Issues

Agency Publication Date: January 26, 2024

Summary

American Contract Systems, Inc. is recalling 42,797 units of various custom procedural convenience kits and trays used in surgeries and medical procedures. The recall was initiated because several components were added to the trays and processed through sterilization without documentation proving they could safely withstand the high temperatures and extended exposure. Affected kits include those used for anesthesia, cardiac catheterization, C-sections, orthopedic surgeries, and neurological procedures nationwide. Consumers and healthcare providers should contact their healthcare provider or the manufacturer for instructions on how to handle affected inventory and potential replacement.

Risk

The affected medical components may lose functionality or experience a decrease in drug effectiveness due to improper sterilization exposure. Additionally, these components may contain higher than specified levels of ethylene oxide residuals, posing a potential health risk to patients during surgical procedures.

What You Should Do

Identify if you have any of the hundreds of affected kits, such as the HEART ANESTHESIA BUNDLE (LMHA01V), C-SECTION PACK (LLCI66), or TOTAL HIP PACK (GNTH06L), by checking the kit numbers and lot numbers on the outer packaging.
Review the extensive list of affected lot numbers and expiration dates, which include lots like 702221 (Exp 10/25/223), 654221 (Exp 12/12/2023), 954231 (Exp 2/15/2024), and 903231 (Exp 4/7/2024) across various product categories.
Check the Unique Device Identifier (UDI/DI) codes where available, such as 00191072164240 for heart catheterization trays or 00191072162755 for adult craniotomy packs.
Stop using all affected procedural kits and trays immediately and quarantine them to prevent use in medical procedures.
Contact American Contract Systems, Inc. at their facility in Temple Terrace, Florida, or reach out to your healthcare provider for specific instructions on returning or replacing the affected devices.
For further information or 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

Other Action

Quarantine and contact manufacturer

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

Affected Products

Product: Custom procedural convenience kits and trays, anesthesia (HEART ANESTHESIA BUNDLE NS)

Model / REF:

LMHA01V

Lot Numbers:

702221 (Exp 10/25/223)

654221 (Exp 12/12/2023)

954231 (Exp 2/15/2024)

903231 (Exp 4/7/2024)

Date Ranges: 10/25/223, 12/12/2023, 2/15/2024, 4/7/2024

Product: Custom procedural convenience kits and trays, anesthesia (OR/Anesthesia Central Line Insertion Kit)

Model / REF:

UIAN43L

Lot Numbers:

654221 (Exp 12/12/2023)

991231 (Exp 1/9/2024)

Date Ranges: 12/12/2023, 1/9/2024

Product: Custom procedural convenience kits and trays, cardiac (HEART CATHETERIZATION TRAY)

Model / REF:

JRHC45G

UPC Codes:

00191072164240

Lot Numbers:

912231 (Exp 3/29/2024)

920231 (Exp 3/21/2024)

952231 (Exp 2/17/2024)

963231 (Exp 2/6/2024)

976231 (Exp 6/2/2023)

654221 (Exp 12/12/2023)

714221 (Exp 10/13/2023)

717221 (Exp 6/7/2023)

766221 (Exp 8/22/2023)

814221 (Exp 7/5/2023)

Date Ranges: 3/29/2024, 3/21/2024, 2/17/2024, 2/6/2024, 6/2/2023, 12/12/2023, 10/13/2023, 6/7/2023, 8/22/2023, 7/5/2023

Product: Custom procedural convenience kits and trays, cardiac (TAVR PACK)

Model / REF:

LLTV10

UPC Codes:

00191072183255

Lot Numbers:

644221 (Exp 12/22/2023)

973231 (Exp 1/27/2024)

952231 (Exp 2/17/2024)

924231 (Exp 3/17/2024)

Date Ranges: 12/22/2023, 1/27/2024, 2/17/2024, 3/17/2024

Product: Custom procedural convenience kits and trays, cardiac (CATH PED LF SJH)

Model / REF:

SJCA21F

Lot Numbers:

666221 (Exp 11/30/2023)

701221 (Exp 10/26/2023)

747221 (Exp 9/10/2023)

779221 (Exp 8/9/2023)

807221 (Exp 7/12/2023)

846221 (Exp 6/3/2023)

919231 (Exp 3/22/2024)

954231 (Exp 2/15/2024)

988231 (Exp 1/12/2024)

Date Ranges: 11/30/2023, 10/26/2023, 9/10/2023, 8/9/2023, 7/12/2023, 6/3/2023, 3/22/2024, 2/15/2024, 1/12/2024

Product: Custom procedural convenience kits and trays, cardiac (CATH HEART ADL LF SJH)

Model / REF:

SJCH22F

Lot Numbers:

670221 (Exp 11/26/2023)

708221 (Exp 10/19/2023)

747221 (Exp 9/10/2023)

795221 (Exp 7/24/2023)

834221 (Exp 6/15/2023)

873221 (Exp 5/7/2023)

937231 (Exp 3/4/2024)

991231 (Exp 1/9/2024)

Date Ranges: 11/26/2023, 10/19/2023, 9/10/2023, 7/24/2023, 6/15/2023, 5/7/2023, 3/4/2024, 1/9/2024

Product: Custom procedural convenience kits and trays, cardiac (INT RAD PORTS-LF - 206060)

Model / REF:

UDIR58AL

Lot Numbers:

682221 (Exp 11/14/2023)

638221 (Exp 7/31/2023)

963231 (Exp 2/6/2024)

925231 (Exp 3/16/2024)

883231 (Exp 10/30/2023)

Date Ranges: 11/14/2023, 7/31/2023, 2/6/2024, 3/16/2024, 10/30/2023

Product: Custom procedural convenience kits and trays, ear, nose & throat (T AND A PACK AGH ASC)

Model / REF:

AGTA48J

UPC Codes:

00191072142870

Lot Numbers:

890231

920231

941231

976231

645221

659221

686221

755221

836221

Product: Custom procedural convenience kits and trays, gastroenterological & urological (AHN BIOPSY STERILE)

Model / REF:

AHBP12A

UPC Codes:

00191072188229

Lot Numbers:

963231 (Exp 1/21/2024)

940231 (Exp 1/21/2024)

996231 (Exp 2/28/2023)

Date Ranges: 1/21/2024, 2/28/2023

Product: Custom procedural convenience kits and trays, general hospital use (Baby PICC Kit)

Model / REF:

UIBP90J

UPC Codes:

00191072117038

Lot Numbers:

996231 (Exp 1/4/2024)

Date Ranges: 1/4/2024

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93656

Status: Active

Manufacturer: American Contract Systems, Inc.

Sold By: Hospital supply networks; Medical distributors

Manufactured In: United States

Units Affected: 18 products (182 units; 4394 units; 12291 units; 290 units; 804 units; 95 units; 3196 units; 1031 units; 112 units; 7881 units; 244 units; 2717 units; 1020 units; 114 units; 1818 units; 144 units; 940 units; 5524 units)

Distributed To: Nationwide

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 · 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.

Summary

Risk

What You Should Do

Identify if you have any of the hundreds of affected kits, such as the HEART ANESTHESIA BUNDLE (LMHA01V), C-SECTION PACK (LLCI66), or TOTAL HIP PACK (GNTH06L), by checking the kit numbers and lot numbers on the outer packaging.

Review the extensive list of affected lot numbers and expiration dates, which include lots like 702221 (Exp 10/25/223), 654221 (Exp 12/12/2023), 954231 (Exp 2/15/2024), and 903231 (Exp 4/7/2024) across various product categories.

Check the Unique Device Identifier (UDI/DI) codes where available, such as 00191072164240 for heart catheterization trays or 00191072162755 for adult craniotomy packs.

Stop using all affected procedural kits and trays immediately and quarantine them to prevent use in medical procedures.

Contact American Contract Systems, Inc. at their facility in Temple Terrace, Florida, or reach out to your healthcare provider for specific instructions on returning or replacing the affected devices.

For further information or 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.

Affected Products

Product: Custom procedural convenience kits and trays, anesthesia (HEART ANESTHESIA BUNDLE NS)

Model / REF:

LMHA01V

Lot Numbers:

702221 (Exp 10/25/223)

654221 (Exp 12/12/2023)

954231 (Exp 2/15/2024)

903231 (Exp 4/7/2024)

Date Ranges: 10/25/223, 12/12/2023, 2/15/2024, 4/7/2024

Product: Custom procedural convenience kits and trays, anesthesia (OR/Anesthesia Central Line Insertion Kit)

Model / REF:

UIAN43L

Lot Numbers:

654221 (Exp 12/12/2023)

991231 (Exp 1/9/2024)

Date Ranges: 12/12/2023, 1/9/2024

Product: Custom procedural convenience kits and trays, cardiac (HEART CATHETERIZATION TRAY)

Model / REF:

JRHC45G

UPC Codes:

00191072164240

Lot Numbers:

912231 (Exp 3/29/2024)

920231 (Exp 3/21/2024)

952231 (Exp 2/17/2024)

963231 (Exp 2/6/2024)

976231 (Exp 6/2/2023)

654221 (Exp 12/12/2023)

714221 (Exp 10/13/2023)

717221 (Exp 6/7/2023)

766221 (Exp 8/22/2023)

814221 (Exp 7/5/2023)

Date Ranges: 3/29/2024, 3/21/2024, 2/17/2024, 2/6/2024, 6/2/2023, 12/12/2023, 10/13/2023, 6/7/2023, 8/22/2023, 7/5/2023

Product: Custom procedural convenience kits and trays, cardiac (TAVR PACK)

Model / REF:

LLTV10

UPC Codes:

00191072183255

Lot Numbers:

644221 (Exp 12/22/2023)

973231 (Exp 1/27/2024)

952231 (Exp 2/17/2024)

924231 (Exp 3/17/2024)

Date Ranges: 12/22/2023, 1/27/2024, 2/17/2024, 3/17/2024

Product: Custom procedural convenience kits and trays, cardiac (CATH PED LF SJH)

Model / REF:

SJCA21F

Lot Numbers:

666221 (Exp 11/30/2023)

701221 (Exp 10/26/2023)

747221 (Exp 9/10/2023)

779221 (Exp 8/9/2023)

807221 (Exp 7/12/2023)

846221 (Exp 6/3/2023)

919231 (Exp 3/22/2024)

954231 (Exp 2/15/2024)

988231 (Exp 1/12/2024)

Date Ranges: 11/30/2023, 10/26/2023, 9/10/2023, 8/9/2023, 7/12/2023, 6/3/2023, 3/22/2024, 2/15/2024, 1/12/2024

Product: Custom procedural convenience kits and trays, cardiac (CATH HEART ADL LF SJH)

Model / REF:

SJCH22F

Lot Numbers:

670221 (Exp 11/26/2023)

708221 (Exp 10/19/2023)

747221 (Exp 9/10/2023)

795221 (Exp 7/24/2023)

834221 (Exp 6/15/2023)

873221 (Exp 5/7/2023)

937231 (Exp 3/4/2024)

991231 (Exp 1/9/2024)

Date Ranges: 11/26/2023, 10/19/2023, 9/10/2023, 7/24/2023, 6/15/2023, 5/7/2023, 3/4/2024, 1/9/2024

Product: Custom procedural convenience kits and trays, cardiac (INT RAD PORTS-LF - 206060)

Model / REF:

UDIR58AL

Lot Numbers:

682221 (Exp 11/14/2023)

638221 (Exp 7/31/2023)

963231 (Exp 2/6/2024)

925231 (Exp 3/16/2024)

883231 (Exp 10/30/2023)

Date Ranges: 11/14/2023, 7/31/2023, 2/6/2024, 3/16/2024, 10/30/2023

Product: Custom procedural convenience kits and trays, ear, nose & throat (T AND A PACK AGH ASC)

Model / REF:

AGTA48J

UPC Codes:

00191072142870

Lot Numbers:

890231

920231

941231

976231

645221

659221

686221

755221

836221

Product: Custom procedural convenience kits and trays, gastroenterological & urological (AHN BIOPSY STERILE)

Model / REF:

AHBP12A

UPC Codes:

00191072188229

Lot Numbers:

963231 (Exp 1/21/2024)

940231 (Exp 1/21/2024)

996231 (Exp 2/28/2023)

Date Ranges: 1/21/2024, 2/28/2023

Product: Custom procedural convenience kits and trays, general hospital use (Baby PICC Kit)

Model / REF:

UIBP90J

UPC Codes:

00191072117038

Lot Numbers:

996231 (Exp 1/4/2024)

Date Ranges: 1/4/2024

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93656

Status: Active

Manufacturer: American Contract Systems, Inc.

Sold By: Hospital supply networks; Medical distributors

Manufactured In: United States

Distributed To: Nationwide