Bard Groshong NXT ClearVue Catheter Recall for Connector Defects
Bard Access Systems is recalling 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 involves a medical device with functional defects that could prevent proper use or locking, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Bard Access Systems Inc. is recalling the Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen. The recall involves specific lots of the device, which is designed for use when central venous catheterization is prescribed.
The recall is being issued because the catheters contain two specific issues. First, the inner diameter of the distal connector may be reduced, resulting 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 in the United States and in various countries such as Australia, Canada, China, and Japan. The source text does not specify the number of units recalled or report any specific injuries or illnesses associated with these defects.
The recalled product
- Product
- REF 9617408, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741036009 - 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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