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U.S. Department of Health and Human Services

Class 2 Device Recall BD Heyman Follower Coude Tip

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 Class 2 Device Recall BD Heyman Follower Coude Tipsee related information
Date Initiated by FirmJune 03, 2025
Date PostedJuly 03, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2075-2025
Recall Event ID 96961
Product Classification Catheter, urological - Product Code KOD
ProductBD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr - REF:021314, 16Fr - REF: 021316
Code Information REF:21312- Lot:JUJX0285 /UDI:801741075605; REF:21314- Lot:JUJX1147 /UDI:801741075612; REF: 21316- Lots:JUJY0895 & JUJX1148 /UDI:801741075629
FEI Number 1018233
Recalling Firm/
Manufacturer		 C.R. Bard Inc
8195 Industrial Blvd Ne
Covington GA 30014-1497
For Additional Information ContactBD Technical Support
1844-823-5433
Manufacturer Reason
for Recall		Cather packaging may contain the incorrect French size.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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