FDAFDA · Food and drugs·Recall number Z-2620-2015
GAUZE SPONGE 2"X2" 8PLY COTTON 1500PK/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Published September 9, 2015 · Recall initiated: July 10, 2015
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
- Code:9002082 Lots: 141216321 exp. 12/31/99 150217375 exp. 12/31/99 150217354 exp. 12/31/99
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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