Bard Access Systems Recalls Replacement Connectors for Groshong NXT PICC Catheters
Bard Access Systems is recalling specific replacement connectors for Groshong NXT PICC catheters due to manufacturing 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 hazard involves a mechanical defect that prevents proper device function (locking/passage), which is a risk-of-harm product issue where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Bard Access Systems Inc. is recalling REF 7812400 Replacement Connectors for 4F Groshong NXT clearVue PICC with Extension Leg. These medical devices are designed for use when central venous catheterization is prescribed and are distributed worldwide, including in the United States and various international markets.
The recall is due to two identified manufacturing issues: the inner diameter of the distal connector may be reduced, resulting in the inability to pass the catheter through the connector, or the catch slot on the distal connector may be deformed, resulting in the inability to properly lock the device. The affected lots include specific lot numbers such as redr1671, reds4453, and others listed in the official recall documentation.
Healthcare providers and patients using these specific replacement connectors should stop using the affected units and contact Bard Access Systems or their medical device supplier for replacement or further instructions. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violation may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- REF 7812400, Replacement Connector For 4F Groshong NXT clearVue PICC with Extension Leg, Rx Only, Sterile EO, CE 2797, UDI: (01)10801741075268 - Product Usage: is designed for use when central venous catheterization is prescribed.
- Manufacturer
- Bard Access Systems Inc.
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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