Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1574-2020·Announced 2020-04-01

Bard Groshong Dual-Lumen Catheters Recalled for Incorrect Tunneler Tip

Bard Peripheral Vascular Inc is recalling 650 Groshong 9.5 Dual-Lumen CV Catheters because they may contain an incorrect tunneler barb tip, potentially prolonging surgical operations.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The source text indicates the hazard results in a 'prolongation of operation' rather than direct physical injury or death, fitting the criteria for a moderate severity recall involving procedural complications without reported harm.

Plain-English summary

Bard Peripheral Vascular Inc is recalling 650 units of Groshong 9.5 Dual-Lumen CV Catheters (Reference numbers 7726950 and 7726954). The recall involves specific lots: RECQ1106 and RECR2195 for reference 7726950, and RECU1837 for reference 7726954.

The firm identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant for a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This manufacturing error can result in a prolongation of the surgical operation.

The affected devices were distributed worldwide, including nationwide distribution in the United States across numerous states and territories, as well as in Brazil, Canada, EMEA, Korea, Mexico, and New Zealand. Healthcare facilities and distributors should stop using the affected lots and contact the manufacturer for instructions on return or replacement.

The recalled product

Product: 1. Groshong 9.5 Dual-Lumen CV Catheter, Ref: 7726950, UDI: (01)00801741041570; 2. Groshong 9.5 F Dual-Lumen CV Catheter, REF: 7726954, UDI: (01)00801741041587
Manufacturer: Bard Peripheral Vascular Inc
Category: Medical Device — Central Venous Catheter
Hazard: manufacturing-error
procedural-complication
Affected units: 650

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 (2)

7726950 Lot # RECQ1106
RECR2195 7726954 Lot # RECU1837

Distribution

Distributed nationwide across the United States.

The notice also names 49 states specifically:

Part of a larger recall action

This product is one of 10 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 10 products in this recall →

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