Bard GlidePath Hemodialysis Catheter Recalled for Tip Damage
Bard Peripheral Vascular Inc. is recalling GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a medical device defect that poses a risk of injury during a procedure is rated as Severe (4), as it is a significant injury risk but not classified as Class I.
Plain-English summary
Bard Peripheral Vascular Inc. is recalling 713 units of the GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet. The specific product code is 5393420, 14.5F, Straight, 42cm length, with UDI 00801741012228. The affected lots are RECZ2997, RECX0854, RECW0386, and RECX1190, with expiration dates ranging from January 31, 2020, to August 31, 2020.
The recall was initiated due to complaints that the molded tip of the tunneler breaks or is damaged during the catheter placement procedure. This defect poses a risk of injury to patients during the medical procedure.
The product was distributed to facilities in 49 US states, the District of Columbia, Puerto Rico, the US Virgin Islands, Australia, and Canada. Healthcare providers and patients should contact Bard Peripheral Vascular Inc. for instructions on how to return or replace the affected devices.
The recalled product
- Product
- GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393420, 14.5F, Straight, 42cm length, BARD, UDI: 00801741012228
- Manufacturer
- Bard Peripheral Vascular Inc
- Hazard
- Affected units
- 713
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 (5)
- (Lot #
- Exp.) RECZ2997 8/31/2020
- RECX0854 3/31/2020
- RECW0386 7/31/2020
- RECX1190 1/31/2020
Distribution
Part of a larger recall action
This product is one of 28 recalled by Bard Peripheral Vascular 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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