The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2380-2019·Announced 2019-09-04

Bard Equistream XK Hemodialysis Catheter Recalled for Tip Breakage

Bard Peripheral Vascular Inc is recalling 46 units of Equistream XK 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, and the hazard involves a structural defect in a medical device that can cause injury during a procedure, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Bard Peripheral Vascular Inc is recalling 46 units of Equistream XK Long-Term Hemodialysis Catheters with Preloaded Stylet (REF/Product code: 5913350, 16F, Straight, 35cm length). The specific lot number is RECZ0711, with an expiration date of 9/30/2020.

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 affected units were distributed across 48 US states, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, Australia, and Canada. Healthcare facilities and patients who have received these specific catheters should contact Bard Peripheral Vascular Inc or their local FDA office for further instructions on how to proceed.

The recalled product

Product
EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913350, 16F, Straight, 35cm length, BARD, UDI: 00801741013874
Manufacturer
Bard Peripheral Vascular Inc
Category
Medical Device — Hemodialysis Catheter
Hazard
Affected units
46

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 # RECZ0711 Exp. 9/30/2020

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 →

Related recalls

Same manufacturer · Bard Peripheral Vascular Inc

See all →

Same hazard · structural defect

See all →

Similar recalls