Breast Abdominoplasty Pack
Reported: September 14, 2022 Initiated: June 16, 2022 #Z-1697-2022
Product Description
Breast Abdominoplasty Pack
Reason for Recall
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Details
- Recalling Firm
- American Contract Systems, Inc.
- Units Affected
- 1 unit
- Distribution
- 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
- Location
- Kansas City, MO
Frequently Asked Questions
What product was recalled? ▼
Breast Abdominoplasty Pack. Recalled by American Contract Systems, Inc.. Units affected: 1 unit.
Why was this product recalled? ▼
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 14, 2022. Severity: Moderate. Recall number: Z-1697-2022.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11