Z-2120-2017 Class II Terminated
FDA device recall Z-2120-2017 was initiated by Bard Access Systems Inc. on April 25, 2017 and is designated Class II. Reason for recall: StatLockTM IV Premium Catheter Stabilization Device may contain an incorrectly sized retainer clip. The recall status is terminated (terminated August 21, 2017). Affected quantity: 4,500 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 31, 2017
- Initiation Date
- April 25, 2017
- Termination Date
- August 21, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,500 units
Product Description
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.
Reason for Recall
StatLockTM IV Premium Catheter Stabilization Device may contain an incorrectly sized retainer clip.
Distribution Pattern
Nationwide Distribution - Internationally to Canada. No govt/VA/Military consignees.
Code Information
Lot Number JUAQF675, Exp 2/28/2019