Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614
Recall
- Recall Number
- Z-0905-2026
- Event Number
- 97985
- Firm
- C.R. Bard Inc
- FEI Number
- 1018233
- Product Code
- FAD
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- November 6, 2025
- Posted
- December 11, 2025
- Address
- 8195 Industrial Blvd Ne, Covington, GA, 30014-1497
Description
Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
On Nov. 6, 2025, BD issued a "Urgent Medical Device Recall" Notification to consignees via regional courier service or e-mail. In addition to informing consignees about the recall, BD ask consignees to take the following actions: 1. Immediately Discontinue Use. 2. Please check all inventory locations within your institution for affected BD (C.R. Bard, Inc.) product listed in the Affected Product section below. 3.Immediately quarantine and discard all devices within your facility s control per your facility s procedures. 4. Share this notice with any users of the product within your facilities to ensure they are also aware of this Medical Device Recall (Correction). 5.If you have purchased this product through a distributor, please contact this distributor to request appropriate credit or order alternate replacement product. 6.Complete and return the attached Customer Response Form to the BD contact noted on the form confirming acknowledgement ) 7. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IA, IN, KY, LA, MA, MD, MI, MO, ND, NJ, NY, OH, PA, SD, VA, WA, WI and the countries of Canada, EMEA (Belgium, Denmark, Slovakia, Spain, Turkey, United Kingdom, MENA (Jordan), S Africa), Greater Asia (China).
116 units