Recall Z-2120-2017
Bard Access Systems Inc. · initiated April 25, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot Number JUAQF675, Exp 2/28/2019
Reason for recall
StatLockTM IV Premium Catheter Stabilization Device may contain an incorrectly sized retainer clip.
FDA-determined cause: Process control
Action taken
Bard Access sent an Urgent: Product Recall letter dated May 15, 2017, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please immediately examine your inventory and quarantine any product subject to this notification. Please complete and return the enclosed response form as soon as possible. Bard Access Systems will provide instructions for returning impacted product for credit or replacement upon receipt of the response form. If you have further distributed this product, please identify your customers and inform them of this notification at once. You may include a copy of this letter in your notification to your customers. Please direct all return requests or other questions to our coordinator for credit or replacement product at 1-800-290-1689. We sincerely regret any inconvenience this may cause to you or your facility. For further questions, please call (801) 522-5000.
Details
- Recall number
- Z-2120-2017
- Initiated
- April 25, 2017
- Posted by FDA
- May 19, 2017
- Terminated
- August 21, 2017
- Product code
- KMK – Device, Intravascular Catheter Securement
- Quantity
- 4,500 units
- Distribution
- Nationwide Distribution - Internationally to Canada. No govt/VA/Military consignees.
- Recalling firm
- Bard Access Systems Inc., Salt Lake City, UT