Agency classClass IIOur severity:High FDA (Devices)·Z-1697-2022·Announced 2022-09-14

Breast Abdominoplasty Pack Recalled for Inadequate Sterilization Cycle Validation

American Contract Systems, Inc. is recalling Breast Abdominoplasty Packs that were exposed to multiple sterilization cycles without validation that the process could safely maintain instrument sterility through repeated exposures.

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: This is an FDA Class II recall of surgical instruments where the sterilization validation process was inadequate for multiple cycles, creating a theoretical risk-of-harm scenario. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury score at most 3.

Plain-English summary

American Contract Systems, Inc. is recalling its Breast Abdominoplasty Pack, a surgical instrument tray used in breast and abdominal cosmetic surgery procedures.

The product was exposed to multiple sterilization cycles without validation that the sterilization process could safely and effectively maintain proper instrument sterility when repeated. The manufacturer had not verified that the sterilization process adequately sterilizes the instruments after multiple exposure cycles, creating a potential risk that instruments may not be properly sterilized before surgical use.

The affected packs were distributed to health systems and distributors across the United States, including Arizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Ohio, Nebraska, Pennsylvania, Rhode Island, South Dakota, and Texas. The specific lot involved is identified by Tray Number SWBA26F, Sterilization Lot 2106091, Lot Number 842211, and Bag Serial Number 64133051-006.

Healthcare facilities that received these packs should discontinue use and contact American Contract Systems, Inc. for information regarding replacement or return of the recalled product.

The recalled product

Product: Breast Abdominoplasty Pack
Manufacturer: American Contract Systems, Inc.
Category: Medical Device — Surgical Instruments
Hazard: sterilization-failure
infection-risk
Affected units: 1

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 (7)

Tray Number
Sterilization Lot
Lot Number
Bag Serial Number 1) SWBA26F
2106091
842211
64133051-006

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 →

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