FDAOctober 1, 2019device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.

What to do

FDA enforcement status: Terminated

Brands named

bard peripheral vascularbardbard peripheral

UPCs

0080174104157000801741041587

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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