The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1663-2021·Announced 2021-05-26

Bard Groshong NXT ClearVue Catheter Recalled for Connector Defects

Bard Access Systems is recalling specific lots of Groshong NXT ClearVue Catheters due to defects in the distal connector that may prevent proper catheter passage or locking.

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 functional defect in a medical device used for central venous catheterization, which poses a risk of harm if the device fails to lock or pass through the connector, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Bard Access Systems Inc. is recalling specific lots of the Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen. The recall involves Lot Nos. REDT1691, reeu3507, and reew4280. These medical devices are designed for use when central venous catheterization is prescribed.

The recall was initiated because the catheters contain two specific issues. First, the inner diameter of the distal connector may be reduced, which can result in the inability to pass the catheter through the connector. Second, the catch slot on the distal connector may be deformed, resulting in the inability to properly lock the device.

The affected products were distributed worldwide, including nationwide distribution in the United States and in various countries such as Australia, Canada, China, and Japan. Healthcare providers and facilities should check their inventory for the specific lot numbers listed and stop using the affected devices. Consumers are advised to contact their healthcare provider if they have been treated with these specific devices.

The recalled product

Product
REF 9655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741036023 - Product Usage: is designed for use when central venous catheterization is prescribed.
Manufacturer
Bard Access Systems Inc.
Category
Medical Device — Catheters
Hazard

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 No. REDT1691
  • reeu3507
  • reew4280

Distribution

Distributed nationwide across the United States.

The notice also names 33 states specifically:

Part of a larger recall action

This product is one of 18 recalled by Bard Access Systems 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 18 products in this recall →

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