Device product
GENERAL MINOR PK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Z-2704-2015
Product summary
- Firm
- Customed, Inc
- Event
- Event 71721
- Status
- Terminated
- Classification
- Class II
- Quantity
- 425
- Official record key
device-enforcement:Z-2704-2015
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:900787 Lots: 140915506 exp. 10/31/15 140915506 exp. 10/31/15 140915506 exp. 10/31/15 150116821 exp. 6/30/19 150116820 exp. 2/28/16 150116822 exp. 2/28/16 150116823 exp. 2/28/16 150317878 exp. 3/31/16 150317879 exp. 3/31/16 150317659 exp. 3/31/16 150317880 exp. 3/31/16 150317660 exp. 3/31/16 150317661 exp. 3/31/16 150418264 exp. 4/30/16
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