Agency classClass IIOur severity:High FDA (Devices)·Z-2369-2019·Announced 2019-09-04

Bard Equistream Hemodialysis Catheter Recalled for Tip Breakage

Bard Peripheral Vascular Inc is recalling 135 units of Equistream 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 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 structural defect in a medical device that can cause injury during a procedure, but the source text does not report any confirmed injuries or illnesses, placing it in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Bard Peripheral Vascular Inc is recalling 135 units of Equistream Long-Term Hemodialysis Catheters, specifically the 14.5 Fr. Alphacurve Catheter with Standard Kit, 24cm length (REF/Product code: 5905240, UDI# 00801741013805). The recall is limited to lot RECX3120 with an expiration date of 8/31/2020.

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 or procedural failure during the medical intervention.

The affected units were distributed across 49 US states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands, as well as in Australia and Canada. Healthcare facilities and patients who have received or are scheduled to receive this specific lot of catheters should contact Bard Peripheral Vascular Inc or their medical provider for instructions on replacement or alternative treatment options.

The recalled product

Product: EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905240, 14.5 Fr. Alphacurve Catheter with Standard Kit, 24cm length, BARD, UDI# 00801741013805
Manufacturer: Bard Peripheral Vascular Inc
Category: Medical Device — Hemodialysis Catheter
Hazard: structural-defect
injury
Affected units: 135

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 (3)

(Lot
Exp) RECX3120
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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