Device product
SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult
Z-1366-2021
Product summary
- Event
- Event 87432
- Status
- Terminated
- Classification
- Class II
- Quantity
- 129 units (63 units for Human-use and 66 units for Non-Human use)
- Official record key
device-enforcement:Z-1366-2021
Official wording
Reason: Non-conformity (holes/punctures or deep creases) in the sterile barrier.
Code information: Catalogue Number: 100-36-01 Lot Number: 0818-009
Distribution pattern: U.S.: AZ, FL, MI, OH, TX, and WI. O.U.S.: None
Derived failure modes
-
Unknown
Non-conformity (holes/punctures or deep creases) in the sterile barrier.