Bard recalls GlidePath long-term hemodialysis catheters with preloaded stylet (model 5397310) due to molded tunneler tip breaking during placement, risking complications for dialysis patients.
The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
Bard is recalling GlidePath long-term hemodialysis catheters with preloaded stylet (model 5397310) because the molded tip of the tunneler can break during catheter placement. This breakage could cause complications for patients receiving dialysis treatments.
The molded tip of the tunneler can break during catheter placement, potentially causing complications for patients. This breakage could lead to issues with the catheter's function during dialysis treatments.
Patients using hemodialysis treatments with this specific catheter model are most at risk. Healthcare providers who place these catheters during dialysis procedures may also be affected.
Check for the model number 5397310 on the catheter packaging or label. The catheter has a 14.5F size, straight configuration, and 31cm length. It was manufactured with lot number RECX0642 and expires March 31, 2020.
Verify the model number on the catheter label or packaging to confirm if it matches 5397310.
Reach out to your healthcare provider to discuss potential catheter replacement if you have this model.
The molded tip of the tunneler can break during catheter placement, potentially causing complications for patients receiving dialysis treatments.
Check the model number on the catheter label or packaging. If it matches 5397310, contact your healthcare provider to discuss potential replacement.
The official recall notice does not specify a deadline for action.
We’ve drafted a message you can send Bard to request your refund or repair — edit it as you like.
Subject: Recall Z-2393-2019 — Bard Bard Hello, I own a Bard that is covered by recall Z-2393-2019 from Bard. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
