Bard Groshong NXT ClearVue 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 involves a medical device with functional defects that could prevent proper use or locking, representing a risk-of-harm product where specific injury reports are not detailed in the source text.
Plain-English summary
Bard Access Systems Inc. is recalling specific lots of REF 7617407, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm. The recall affects units with Lot Nos. redy3816, REEP1719, REEW2787, and REEX1087. These medical devices are designed for use when central venous catheterization is prescribed.
The recall was initiated because the catheters contain two potential issues. First, the inner diameter of the distal 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.
The affected products were distributed worldwide and nationwide in the United States, including in states such as AK, AL, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, and WI. International distribution included Australia, Belgium, Canada, China, Japan, Taiwan, Hong Kong, Malaysia, Chile, Bangladesh, Korea, Brazil, India, Singapore, and Thailand. Healthcare facilities and consumers should stop using the affected lots and contact Bard Access Systems for further instructions.
The recalled product
- Product
- REF 7617407, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035248 - Product Usage: is designed for use when central venous catheterization is prescribed.
- Manufacturer
- Bard Access Systems Inc.
- Category
- Medical Device — Catheter
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 (4)
- Lot No. redy3816
- REEP1719
- REEW2787
- REEX1087
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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