Device product
Catalog Number: 900110 TRACHEOSTOMY CARE KIT WITH TRACH TUBE HOLDER FOR ADULT Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Z-1411-2016
Product summary
- Firm
- Customed, Inc
- Event
- Event 72992
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2800
- Official record key
device-enforcement:Z-1411-2016
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: LOTS: SL15170 (150619116) 30-JUN-16 SL15175 (150619116) 30-JUN-16 SV15168 (150518601) 30-JUN-16 SV15168 (150318049) 30-JUN-16 SL15199 (150719623) 31-JUL-16 SL15224 (150719623) 31-JUL-16 SL15225 (150820150) 31-AUG-16 SL15264 (150920928) 30-SEP-16 SL15264 (150920679) 30-SEP-16 SL15268 (150920928) 30-SEP-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