The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2384-2019·Announced 2019-09-04

Bard Hemodialysis Catheter Recalled for Molded Tip Breakage During Placement

Bard Peripheral Vascular Inc is recalling GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during the placement procedure.

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 mechanical defect (tip breakage) during a medical procedure, which poses a risk of harm, but the source text does not report specific injuries or fatalities, aligning with 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 the GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet. The recall involves 10,507 units of the 14.5F, Straight, 23cm length catheter (REF/Product code: 5393230, UDI: 00801741012181). The affected lots have expiration dates ranging from March 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. The product was distributed to facilities in all 50 U.S. states, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, Australia, and Canada.

This is a Class II recall, meaning there is a reasonable probability that the use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences. Healthcare providers should stop using the affected lots and contact Bard Peripheral Vascular Inc for further instructions.

The recalled product

Product
GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393230, 14.5F, Straight, 23cm length, BARD, UDI: 00801741012181
Manufacturer
Bard Peripheral Vascular Inc
Category
Medical Device — Hemodialysis Catheter
Hazard
Affected units
10,507

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 (14)

  • (Lot #
  • Exp.) REDN1423 8/31/2020
  • REDN0141 4/30/2020
  • RECZ2974 8/31/2020
  • RECZ0639 3/31/2020
  • RECZ1098 3/31/2020
  • RECY7435 3/31/2020
  • RECX2895 3/31/2020
  • RECX1714 4/30/2020
  • RECX0653 3/31/2020
  • RECW2371 4/30/2020
  • RECW1714 6/30/2020
  • RECX0998 7/31/2020
  • RECV2487 8/31/2020

Distribution

Distributed in 53 states:

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.

See all 28 products in this recall →

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