Device product

Breast Abdominoplasty Pack

Z-1697-2022

June 16, 2022

Class II

Product summary

Firm: American Contract Systems, Inc.
Event: Event 90574
Status: Ongoing
Classification: Class II
Quantity: 1 unit
Official record key: device-enforcement:Z-1697-2022

Official wording

Reason: Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Code information: Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) SWBA26F, 2106091, 842211, 64133051-006

Distribution pattern: Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Product was exposed to multiple sterilization cycles without validation for multiple exposures.