StatLock IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units in

FDA device recall Z-2120-2017 · posted 2017-05-19 · Terminated

Recall details

Recalling firm

Bard Access Systems Inc.

Reason for recall

StatLockTM IV Premium Catheter Stabilization Device may contain an incorrectly sized retainer clip.

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.

Root cause

Process control

Status

Terminated

Product code

KMK

Quantity affected

4,500 units

Distribution

Nationwide Distribution - Internationally to Canada. No govt/VA/Military consignees.

Date initiated

2017-04-25

Date posted

2017-05-19

Date terminated

2017-08-21

Location

Salt Lake City, UT