Bard Hemodialysis Catheter Recalled Due to Molded Tip Breakage
Bard Peripheral Vascular Inc is recalling 140 units of GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or become 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 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: The recall is classified as FDA Class II. The hazard involves a device component breaking during a medical procedure, which presents a risk of harm to patients, but the source text does not report specific injuries or hospitalizations, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Bard Peripheral Vascular Inc is recalling 140 units of GlidePath Long-Term Hemodialysis Catheters with Preloaded stylet (REF/Product code: 5397500, 14.5F, straight, 50cm length). The specific lot number is RECX2780, with an expiration date of 8/31/2020. The product is identified by UDI 00801741012358.
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 affected units were distributed to healthcare facilities in the United States (including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY) and internationally in Australia and Canada. Healthcare providers should stop using the affected units and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397500, 14.5F, straight, 50cm length, BARD, UDI: 00801741012358
- Manufacturer
- Bard Peripheral Vascular Inc
- Affected units
- 140
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 (1)
- Lot # RECX2780 Exp. 8/31/2020
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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