Device product
OPHTHALMIC PACK 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Z-2612-2015
Product summary
- Firm
- Customed, Inc
- Event
- Event 71721
- Status
- Terminated
- Classification
- Class II
- Quantity
- 546
- Official record key
device-enforcement:Z-2612-2015
Official wording
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Code information: Code:9001780 Lots: 141015756 exp. 9/30/16 141216419 exp. 12/31/16 150116978 exp. 2/28/16 150317700 exp. 4/30/16 150317701 exp. 4/30/16 150317702 exp. 4/30/16 150518592 exp. 6/30/16 150518593 exp. 6/30/16 150518594 exp. 6/30/16 150518594 exp. 6/30/16
Distribution pattern: Distributed Only in Puerto Rico.
Derived failure modes
-
Manufacturing or process control
inadequate validation/qualification of sterilization processes
-
Sterility assurance
inadequate validation/qualification of sterilization