The Recall Desk
HighFDA (Devices)·Z-2372-2019·Announced 2019-09-04

Bard Equistream Hemodialysis Catheter Recalled for Molded Tip Breakage

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

What this means for you

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 involves a medical device defect (tip breakage) that poses a risk of harm during a procedure, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Bard Peripheral Vascular Inc is recalling Equistream Long-Term Hemodialysis Catheters with Preloaded Stylet. The specific product code is 5903230, 14.5F, Straight, 23cm length, with UDI 00801741013706. A total of 1,731 units are affected by this recall.

The recall was initiated due to complaints that the molded tip of the tunneler breaks or is damaged during the catheter placement procedure. The affected lots include REDN2487, RECX3053, RECX0505, RECW0964, RECX1188, RECV1544, and RECW0847, with expiration dates ranging from January 31, 2020, to September 30, 2020.

The products were distributed to healthcare facilities in all 50 US states, the District of Columbia, Puerto Rico, the Virgin Islands, Australia, and Canada. Healthcare providers should stop using the affected catheters and contact Bard Peripheral Vascular Inc for instructions on return or replacement.

The recalled product

Product
EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903230, 14.5F, Straight ,23cm length, BARD, UDI: 00801741013706
Manufacturer
Bard Peripheral Vascular Inc
Category
Medical Device — Hemodialysis Catheter
Hazard
Affected units
1,731

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 (8)

  • (Lot #
  • Exp.) REDN2487 9/30/2020
  • RECX3053 3/31/2020
  • RECX0505 7/31/2020
  • RECW0964 7/31/2020
  • RECX1188 8/31/2020
  • RECV1544 1/31/2020
  • RECW0847 1/31/2020

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 →

Related recalls

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Same hazard · device defect

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