Z-1697-2022 Class II Ongoing
FDA device recall Z-1697-2022 was initiated by American Contract Systems, Inc. on Jun 16, 2022 and is designated Class II. Reason for recall: Product was exposed to multiple sterilization cycles without validation for multiple exposures. The recall status is ongoing. Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 14, 2022
- Initiation Date
- Jun 16, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
Breast Abdominoplasty Pack
Reason for Recall
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
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
Code Information
Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) SWBA26F, 2106091, 842211, 64133051-006
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1697-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026