FDAApril 7, 2021device
REF 91660417, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Tip, Basic Kit, 4F, Single-Lumen, TPS, CE 2797, UDI: (01)10801741107822 - Product Usage: is designed for use when central venous catheterization is prescribed.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock
What to do
FDA enforcement status: Terminated
Brands named
bard access systemsbardbard access
UPCs
10801741107822
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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