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.
FDA Recall Z-2120-2017 · Posted 2017-05-19
Recalling FirmBard Access Systems Inc.
Recall StatusTerminated
Product CodeKMK
Date Initiated2017-04-25
Date Terminated2017-08-21
Product Quantity4,500 units
Reason for Recall
StatLockTM IV Premium Catheter Stabilization Device may contain an incorrectly sized retainer clip.
Firm Action
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.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution - Internationally to Canada. No govt/VA/Military consignees.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.