Device product
SNS Disposable Urethral Catheter Electrode, 14 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number UE002
Z-1970-2021
Product summary
- Firm
- Spes Medica
- Event
- Event 87999
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 boxes
- Official record key
device-enforcement:Z-1970-2021
Official wording
Reason: The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
Code information: Lot UR20F2699I
Distribution pattern: Distribution in the following US states: CA, MA, and SC.
Derived failure modes
-
Unknown
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.