Device product
NAMIC CONVENIENCE KIT SELF REGIONAL HEALTHCARE PV LEG PACK, REF Catalog No. 651919311, UPN Product No. H7496519193111 Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire
Z-1343-2016
Product summary
- Event
- Event 72957
- Status
- Terminated
- Classification
- Class II
- Quantity
- 136 kits
- Official record key
device-enforcement:Z-1343-2016
Official wording
Reason: Procedure Products initiated the recall due to the inner lumen of the needles not meeting the intended specification. Specifically, at least a portion of the affected lot is unable to accept a 0.038" guidewire as intended. In some cases the inner lumen was found to be 0.036".
Code information: Batch/Lot No. 4921353 Use By 2018-05 and Batch/Lot No. 4932710 Use By 2018-06-30
Distribution pattern: US Nationwide in the states of CA, IL, MA, SC, TX
Derived failure modes
-
Unknown
Procedure Products initiated the recall due to the inner lumen of the needles not meeting the intended specification. Specifically, at least a portion of the affected lot is unable to accept a 0.038" guidewire as intended. In some cases the inner lumen was found to be 0.036".