Bard Groshong Catheter Recall for Connector and Locking Defects
Bard Access Systems is recalling specific Groshong NXT ClearVue catheters because connector defects may prevent proper catheter passage or locking.
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 with functional defects that could prevent proper use, but the source text does not report any injuries, illnesses, or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Bard Access Systems Inc. is recalling the REF 91660417 Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Tip, Basic Kit, 4F, Single-Lumen, TPS, CE 2797. The recall covers specific lot numbers including redx0702, redx1450, and others listed in the agency record. The product is designed for use when central venous catheterization is prescribed.
The recall is due to two manufacturing issues: the inner diameter of the distal connector may be reduced, resulting in the inability to pass the catheter through the connector, and the catch slot on the distal connector may be deformed, resulting in the inability to properly lock. These defects may prevent the device from functioning as intended during clinical use.
The affected products were distributed worldwide and nationwide in the United States, including in states such as AK, AL, CA, and others, as well as in countries including Australia, Belgium, Canada, and China. Healthcare providers and facilities should check their inventory for the specific lot numbers and stop using the affected devices. Consumers should contact their healthcare provider if they have had this specific device implanted.
The recalled product
- Product
- 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.
- Manufacturer
- Bard Access Systems Inc.
- Category
- Medical Device — Catheter
Distribution
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.
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