FDAFDA · Food and drugs·Recall number Z-2638-2015
MINOR PACK 4/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:9002511 Lots: 140412903 exp. 5/31/16 140915507 exp. 10/31/15 141216305 exp. 12/31/15 150116550 exp. 1/31/16 150116549 exp. 1/31/16 150116552 exp. 1/31/16 150116551 exp. 1/31/16 150317840 exp. 4/30/16 150317839 exp. 4/30/16 150317841 exp. 4/30/16 150317841 exp. 4/30/16 150317842 exp. 4/30/16 150317843 exp. 4/30/16 150317844 exp. 4/30/16 150418372 exp. 4/30/16 150418373 exp. 4/30/16 150418374 exp. 4/30/16 150418375 exp. 5/31/16
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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