Device product
Vascular catheter introduction kit The PICC is indicated for short or long term peripheral access to the central Venous system for intravenous therapy, blood sampling, infusion and power injection of contrast media.
Z-1228-2017
Product summary
- Event
- Event 76237
- Status
- Terminated
- Classification
- Class II
- Quantity
- 215,703 units
- Official record key
device-enforcement:Z-1228-2017
Official wording
Reason: There have been complaints for peel away sheaths flaring
Code information: Material # ASK-01663-MST, ASK-04001-DU4, ASK-04001-DU5, PI-01351-LS, PI-01351-LS5, PI-01351-SS, PI-01552-LS, PI-01552-LS5, PI-01552-SS, PL-05041, PL-05041, PL-05052, PR-05041, PR-05041, PR-05041-T, PR-05042, ASK-01663-MST, ASK-04001-DU4, ASK-04001-DU5, PI-01351-LS, PI-01351-LS5, PI-01351-SS, PI-01351-SS, PI-01451-LS, PI-01451-LS5, PI-01451-SS, PI-01451-SS, PI-0-1552-LS
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
There have been complaints for peel away sheaths flaring