FDAFDA · Food and drugs·Recall number Z-1697-2022
Breast Abdominoplasty Pack
Published September 14, 2022 · Recall initiated: June 16, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- American Contract Systems, Inc.
- Distributor
- 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
- Lot
- Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) SWBA26F, 2106091, 842211, 64133051-006
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.