C.R. Bard Inc recalls BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110
Reason for recall
Cather packaging may contain the incorrect French size.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
BD Heyman Follower Straight Tip for following sizes: 10Fr -7 codes
- 21110
- 12Fr -
- 21112
- 14Fr -
- 21114
- 20Fr -
- 21120
Lot / code information
- REF
- 21110 -
- Lot #
- JUJX0267/
- UDI
- 801741075506
- REF
- 21112 -
- Lot #
- JUJX0258/
- UDI
- 801741075513
- REF
- 21114 - Lots:JUJV0864 & JUJW5009/
- UDI
- 801741075520
- REF
- 21120 -
- Lot #
- JUJY9171/
- UDI
- 801741075551
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What the firm is doing
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
DistributionShow detailsHide
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.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2074-2025
- FDA device classification · KODOfficial FDA classification for this device type
- CFR regulation · 21 CFR 876.5130The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find C.R. Bard IncSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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