Agency classClass IIOur severity:High FDA (Devices)·Z-1698-2022·Announced 2022-09-14

Medical device convenience packs exposed to unvalidated sterilization cycles

American Contract Systems, Inc. is recalling 116 convenience packs distributed to U.S. health systems and distributors in 13 states because they were exposed to multiple sterilization cycles without validation, potentially compromising device sterility assurance.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall involving potential sterility assurance compromise from unvalidated sterilization exposure. No reported illnesses, injuries, or hospitalizations. Classified as risk-of-harm product without reported injury, warranting High severity.

Plain-English summary

American Contract Systems, Inc. is recalling 116 convenience packs that were distributed to health systems and distributors across 13 states: Arizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Ohio, Nebraska, Pennsylvania, Rhode Island, South Dakota, and Texas.

The packs were exposed to multiple sterilization cycles without validation for multiple exposures. This unvalidated reprocessing may compromise the sterility assurance of the devices, potentially affecting their safety and effectiveness.

Health systems and distributors who received affected convenience packs should stop using them and contact American Contract Systems, Inc. for guidance on return or replacement. Facilities should verify whether they have received any of the affected lot numbers listed in the recall notice.

The recalled product

Product: Various convenience packs
Manufacturer: American Contract Systems, Inc.
Category: Medical Device — Sterilized Medical Supplies
Hazard: sterility-assurance-compromise
sterilization-failure
Affected units: 116

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Tray Number
Sterilization Lot
Lot Number
Bag Serial Number 1) LSRICUMXBARB
2104091
905211
14531603 2) LSRBASICPACD
90921+A3:A1061
14798924 3) LSRCFBVIIIPKE
904211
14806477 4) LSRBASICPACD
2105101
881211
14880418 5) LSRMAJBASINC
2106082
860211
44252207 6) LSRMAJBASINC
44251930 7) LSRLATEXTUBA
2106021
855211

Distribution

Distributed in 13 states:

Part of a larger recall action

This product is one of 17 recalled by American Contract Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 17 products in this recall →

Same manufacturer · American Contract Systems, Inc.

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Same hazard · sterility assurance compromise