BD Heyman Follower Straight Tip catheters with incorrect French size packaging
C.R. Bard Inc is recalling BD Heyman Follower Straight Tip catheters because packaging may contain an incorrect French size designation, which could lead to use of the wrong catheter size.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall affecting a medical device (catheter) used in direct patient care. Mislabeling of catheter size poses a risk of harm—use of an incorrect-sized catheter could cause injury—and no reported illnesses or injuries are mentioned in the source text, placing this at the High level per the rubric.
Plain-English summary
C.R. Bard Inc is recalling BD Heyman Follower Straight Tip catheters in sizes 10Fr (REF 21110), 12Fr (REF 21112), 14Fr (REF 21114), and 20Fr (REF 21120). The catheters are being recalled because their packaging may contain an incorrect French size marking.
The affected product has been distributed nationwide throughout the United States and in Canada. The recall affects specific lot numbers: JUJX0267 (10Fr), JUJX0258 (12Fr), JUJV0864 and JUJW5009 (14Fr), and JUJY9171 (20Fr).
If you have received this product, verify the actual catheter size against the packaging label before use. Contact C.R. Bard Inc or your healthcare facility for instructions on returning the affected catheters or obtaining replacement products with correct labeling.
The recalled product
- Product
- BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 21114, 20Fr - REF: 21120
- Manufacturer
- C.R. Bard Inc
- Category
- Medical Device — Catheter
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 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
Distribution
Part of a larger recall action
This product is one of 3 recalled by C.R. Bard Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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