Bard Groshong Catheter Recall for Connector Defects
Bard Access Systems is recalling specific lots of Groshong NXT ClearVue Catheters due to connector defects 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 is classified as FDA Class II. The defects pose a risk of harm by preventing proper catheter function, but the source text does not report any specific injuries or illnesses, 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 specific lots of REF 7617408D Groshong NXT ClearVue Catheters, Maximal Barrier Kit, 4F, Single-Lumen, 60 cm. The recall affects units with lot numbers reev2091, reex1265, reew3144, redx1464, reen4697, and REEP0632. These products were distributed worldwide, including in the United States and various international markets.
The recall is due to two manufacturing defects in the distal connector. First, the inner diameter of the connector may be reduced, which could result 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. These defects may interfere with the intended use of the catheter for central venous catheterization.
Healthcare providers and facilities should identify and remove these specific lots from use. Patients who have received these catheters should contact their healthcare provider for evaluation and potential replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- REF 7617408D, Groshong NXT ClearVue Catheter, Maximal Barrier Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035262 - Product Usage: is designed for use when central venous catheterization is prescribed.
- Manufacturer
- Bard Access Systems Inc.
- Category
- Medical Device — Catheters
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 (6)
- Lot No. reev2091
- reex1265
- reew3144
- redx1464
- reen4697
- REEP0632
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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