Recalls / —

—#214101

Product

REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra

FDA product code

EZC — Catheter, Coude

Device class

Class 2

Medical specialty

Gastroenterology, Urology

510(k) numbers

K910846

Affected lot / code info

Lot # NGJX2513/UDI: 00801741000294

Why it was recalled

Cather packaging may contain the incorrect French size.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On June 3, 2025, BD (C.R. Bard) Urology and Critical Care issued a "Urgent Medical Device Recall Notification to affected consignees via. Fed Ex and E-mail. On June 18, 2025, BD issued a updated recall notification to update incorrect lot numbers. BD asked consignees to take the following actions: 1. Immediately Discontinue Use 2. Please check all inventory locations within your institution for impacted lots of BD C.R. Bard Heyman" Follower Straight Tip Fr Sizes 10, 12, 14, 20; Heyman Follower Coude Tip Fr Sizes 12, 14, 16; BARD Urologist s Trays listed on Attachment 2. 3. Immediately quarantine and discard all impacted 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. 5. Identify all customers within your distribution network that purchased any affected product as defined in this notification. Provide a copy of the attached updated customer letter to all customers to advise them of this field action notification on BD s behalf. 6.If you have purchased this product through a distributor, please contact this distributor to request appropriate credit or order alternate replacement product. 7.Complete and return the attached Customer Response Form to the BD contact noted on the form

Recalling firm

Firm

C.R. Bard Inc

Address

8195 Industrial Blvd Ne, Covington, Georgia 30014-1497

Distribution

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WI, WV and the country of Canada.

Timeline

Recall initiated

2025-06-03

Posted by FDA

2025-07-03

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #214101. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.