Device product
StatLock¿ IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units in tyvek to film pouches, the product is distributed in cartons containing 25 devices and cases containing 250 devices.
Z-2120-2017
Product summary
- Event
- Event 77132
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,500 units
- Official record key
device-enforcement:Z-2120-2017
Official wording
Reason: StatLockTM IV Premium Catheter Stabilization Device may contain an incorrectly sized retainer clip.
Code information: Lot Number JUAQF675, Exp 2/28/2019
Distribution pattern: Nationwide Distribution - Internationally to Canada. No govt/VA/Military consignees.
Derived failure modes
-
Unknown
StatLockTM IV Premium Catheter Stabilization Device may contain an incorrectly sized retainer clip.