Recalls / —
—#150499
Product
BARD INLAY Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
- FDA product code
- FAD — Stent, Ureteral
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- 510(k) numbers
- K983498
- Affected lot / code info
- Product Codes: 776400, 776600, 776700, and 776800.
Why it was recalled
Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.
Root cause (FDA determination)
Labeling Change Control
Action the firm took
Bard Medical sent an Urgent: Medical Device Communication Letter dated October 13, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action required: Examine your inventory and identify any product subject to this notification. If you have any remaining inventory, include a copy of this communication with the unit(s) for future use. If you may have further distributed or transferred this product, please identify the respective organizations and notify them at once of this communication. Your notification to these organizations may be enhanced by including a copy of this product communication letter. This notification should be carried out to the user level. This product notification is being made with the knowledge of the Food and Drug administration. We appreciate your cooperation and assistance in dealing with this matter and sincerely apologize for any inconvenience that may result from this action. For further questions, please call (770) 784-6220.
Recalling firm
- Firm
- C.R. Bard, Inc.
- Address
- 8195 Industrial Blvd NE, Covington, Georgia 30014-1497
Distribution
- Distribution pattern
- U.S. Nationwide.
Timeline
- Recall initiated
- 2016-10-13
- Terminated
- 2022-02-10
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #150499. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.