American Contract Systems, Inc.: Surgical and Medical Packs Recalled for Sterilization Error

Agency Publication Date: October 26, 2023

Summary

American Contract Systems is recalling approximately 2,355 units of various surgical and medical procedural packs because certain internal components were accidentally subjected to an unapproved sterilization process. The affected parts, including I.V. catheters and Dermabond adhesive, were exposed to ethylene oxide and temperatures higher than the manufacturers allowed. These products were distributed in Florida and Iowa and may not work correctly or could contain unsafe chemical residues.

Risk

The sterilization error can cause the medical components to lose their functional effectiveness, reduce the efficacy of any drugs included in the packs, and result in higher-than-specified chemical (ethylene oxide) residues, potentially causing patient injury during medical procedures.

What You Should Do

Identify if you have the affected packs by checking the 'REF' number and Lot numbers on the product packaging. Affected models include: General Pack (REF BBGP31C), LAVH (REF BBLV21C), Breast Plastics Pack (REF BBPL20D), Robotics Pack SAH (REF SAR530M), CVS PCSU SJH (REF SJCV48J), Pediatric Heart SJH (REF SJPH34K), Vasc. Open CVOR SJH (REF SJVO56B), Robotics Pack (REF SJVO56B/SSRO22D), Sub Q Recorder Pack (REF BPRC87A), Pediatric Urology Wolson Pack (REF BPPU55A), and Cath Cardiac Pack (REF IHCC03V).
Specifically check for the following lot numbers: 968231, 686221, 756221, 782221, 862221, 949231, 983231, 945231, 954231, 974231, 975231, 940231, 965231, 933231, 987231, 969231, 923231, 977231, 724221, and 679221.
Stop using any products from the affected lot numbers immediately to avoid potential procedure failure or chemical exposure.
Contact your healthcare provider or American Contract Systems, Inc. at their Florida facility for further instructions regarding the return or replacement of these medical devices.
For additional information, contact the FDA directly at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer communication regarding unapproved sterilization process.

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

Affected Products

Product: General Pack, REF BBGP31C

Model / REF:

BBGP31C

UPC Codes:

00191072166609

Lot Numbers:

968231

Product: LAVH, REF BBLV21C

Model / REF:

BBLV21C

UPC Codes:

00191072166234

Lot Numbers:

686221

Product: Breast Plastics Pack, REF BBPL20D

Model / REF:

BBPL20D

UPC Codes:

00191072166241

Lot Numbers:

756221

782221

862221

Product: Robotics Pack SAH, REF SAR530M

Model / REF:

SAR530M

UPC Codes:

00191072179678

Lot Numbers:

949231

983231

Product: CVS PCSU SJH, REF SJCV48J

Model / REF:

SJCV48J

UPC Codes:

00191072167903

Lot Numbers:

945231

954231

974231

Product: Pediatric Heart SJH, REF SJPH34K

Model / REF:

SJPH34K

UPC Codes:

00191072167064

Lot Numbers:

975231

Product: Vasc. Open CVOR SJH, REF SJVO56B

Model / REF:

SJVO56B

UPC Codes:

00191072182869

Lot Numbers:

940231

974231

Product: Robotics Pack, REF SJVO56B

Model / REF:

SJVO56B

UPC Codes:

00191072122339

Lot Numbers:

965231

Product: Robotics Pack, REF SSRO22D

Model / REF:

SSRO22D

UPC Codes:

00191072167705

Lot Numbers:

933231

987231

Product: Sub Q Recorder Pack, REF BPRC87A

Model / REF:

BPRC87A

UPC Codes:

00191072187970

Lot Numbers:

969231

Product: Pediatric Urology Wolson Pack, REF BPPU55A

Model / REF:

BPPU55A

UPC Codes:

00191072187949

Lot Numbers:

923231

977231

Product: Cath Cardiac Pack, REF IHCC03V

Model / REF:

IHCC03V

UPC Codes:

00191072189431

Lot Numbers:

724221

679221

945231

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93086

Status: Active

Manufacturer: American Contract Systems, Inc.

Sold By: Hospitals and medical facilities

Manufactured In: United States

Units Affected: 12 products (57 cases; 18 cases; 20 cases; 96 cases; 36 cases; 72 cases; 84 cases; 112 cases; 56 cases; 96 cases; 448 cases; 1260 units)

Distributed To: Florida, Iowa

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

What You Should Do

Identify if you have the affected packs by checking the 'REF' number and Lot numbers on the product packaging. Affected models include: General Pack (REF BBGP31C), LAVH (REF BBLV21C), Breast Plastics Pack (REF BBPL20D), Robotics Pack SAH (REF SAR530M), CVS PCSU SJH (REF SJCV48J), Pediatric Heart SJH (REF SJPH34K), Vasc. Open CVOR SJH (REF SJVO56B), Robotics Pack (REF SJVO56B/SSRO22D), Sub Q Recorder Pack (REF BPRC87A), Pediatric Urology Wolson Pack (REF BPPU55A), and Cath Cardiac Pack (REF IHCC03V).

Specifically check for the following lot numbers: 968231, 686221, 756221, 782221, 862221, 949231, 983231, 945231, 954231, 974231, 975231, 940231, 965231, 933231, 987231, 969231, 923231, 977231, 724221, and 679221.

Stop using any products from the affected lot numbers immediately to avoid potential procedure failure or chemical exposure.

Contact your healthcare provider or American Contract Systems, Inc. at their Florida facility for further instructions regarding the return or replacement of these medical devices.

For additional information, contact the FDA directly at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: General Pack, REF BBGP31C

Model / REF:

BBGP31C

UPC Codes:

00191072166609

Lot Numbers:

968231

Product: LAVH, REF BBLV21C

Model / REF:

BBLV21C

UPC Codes:

00191072166234

Lot Numbers:

686221

Product: Breast Plastics Pack, REF BBPL20D

Model / REF:

BBPL20D

UPC Codes:

00191072166241

Lot Numbers:

756221

782221

862221

Product: Robotics Pack SAH, REF SAR530M

Model / REF:

SAR530M

UPC Codes:

00191072179678

Lot Numbers:

949231

983231

Product: CVS PCSU SJH, REF SJCV48J

Model / REF:

SJCV48J

UPC Codes:

00191072167903

Lot Numbers:

945231

954231

974231

Product: Pediatric Heart SJH, REF SJPH34K

Model / REF:

SJPH34K

UPC Codes:

00191072167064

Lot Numbers:

975231

Product: Vasc. Open CVOR SJH, REF SJVO56B

Model / REF:

SJVO56B

UPC Codes:

00191072182869

Lot Numbers:

940231

974231

Product: Robotics Pack, REF SJVO56B

Model / REF:

SJVO56B

UPC Codes:

00191072122339

Lot Numbers:

965231

Product: Robotics Pack, REF SSRO22D

Model / REF:

SSRO22D

UPC Codes:

00191072167705

Lot Numbers:

933231

987231

Product: Sub Q Recorder Pack, REF BPRC87A

Model / REF:

BPRC87A

UPC Codes:

00191072187970

Lot Numbers:

969231

Product: Pediatric Urology Wolson Pack, REF BPPU55A

Model / REF:

BPPU55A

UPC Codes:

00191072187949

Lot Numbers:

923231

977231

Product: Cath Cardiac Pack, REF IHCC03V

Model / REF:

IHCC03V

UPC Codes:

00191072189431

Lot Numbers:

724221

679221

945231

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93086

Status: Active

Manufacturer: American Contract Systems, Inc.

Sold By: Hospitals and medical facilities

Manufactured In: United States

Units Affected: 12 products (57 cases; 18 cases; 20 cases; 96 cases; 36 cases; 72 cases; 84 cases; 112 cases; 56 cases; 96 cases; 448 cases; 1260 units)

Distributed To: Florida, Iowa