Agency classClass IIOur severity:High FDA (Devices)·Z-2373-2019·Announced 2019-09-04

Bard Equistream Hemodialysis Catheter Recall Due to Tip Breakage

Bard Peripheral Vascular Inc is recalling 161 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, and the hazard involves a structural defect (tip breakage) during a medical procedure, which poses a risk of harm even though specific injuries are not detailed in the source text.

Plain-English summary

Bard Peripheral Vascular Inc is recalling 161 units of Equistream Long-Term Hemodialysis Catheters with Preloaded Stylet. The affected product is identified by Reference/Product code 5903270, 14.5F, Straight, 27cm length, and UDI 00801741013713. The specific lot number is RECW0913, with an expiration date of 3/31/2020.

The recall was initiated due to complaints that the molded tip of the tunneler breaks or is damaged during the catheter placement procedure. The agency has classified this as a Class II recall.

The affected units were distributed across numerous US states and territories, 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, and WY, as well as in Australia and Canada. Healthcare providers and patients should check their inventory and records for this specific lot and contact the manufacturer for further instructions.

The recalled product

Product: EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903270, 14.5F, Straight ,27cm length, BARD, UDI: 00801741013713
Manufacturer: Bard Peripheral Vascular Inc
Category: Medical Device — Hemodialysis Catheter
Hazard: structural-defect
device-failure
Affected units: 161

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 # RECW0913 Exp. 3/31/2020

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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