FDAFDA · Food and drugs·Recall number Z-1465-2016
Catalog Number: 9003190 SURG GOWN SMS AMMI IV FULL Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Published April 20, 2016 · Recall initiated: January 7, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Customed, Inc
- Distributor
- Distributed only in Puerto Rico.
- Lot
- LOTS: SL15195-02 (150619269) 31-JUL-16 SL15251 (150820570) 31-AUG-16
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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