Z-1228-2017 Class II Terminated
FDA device recall Z-1228-2017 was initiated by Arrow International Inc on January 11, 2017 and is designated Class II. Reason for recall: There have been complaints for peel away sheaths flaring The recall status is terminated (terminated September 6, 2018). Affected quantity: 215,703 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 1, 2017
- Initiation Date
- January 11, 2017
- Termination Date
- September 6, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 215,703 units
Product Description
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.
Reason for Recall
There have been complaints for peel away sheaths flaring
Distribution Pattern
Nationwide Distribution
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