Device product
Regard Custom Surgical Pack, Item Number: 800208002; Sterile, CV0361B - CABG A&B. Used in cardiovascular surgical procedures.
Z-2799-2015
Product summary
- Event
- Event 72008
- Status
- Terminated
- Classification
- Class II
- Quantity
- 67 kits
- Official record key
device-enforcement:Z-2799-2015
Official wording
Reason: Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance.
Code information: 025072B
Distribution pattern: Distributed to one customer in Lake Charles, LA and one customer in Spartanburg, SC.
Derived failure modes
-
Unknown
Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance.