Bard recalls EQUISTREAM XK Long-Term Hemodialysis Catheters with preloaded stylet (REF 5913350) due to molded tip breaking during placement, risking complications. Affected units have specific model and lot numbers.
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 certain long-term hemodialysis catheters because the tunneler tip can break during placement. This breakage may cause complications for patients needing dialysis treatment.
The molded tip of the tunneler can break during catheter placement. This breakage could lead to complications like infection or improper catheter function in patients requiring long-term dialysis.
Patients using hemodialysis treatments with this specific catheter model are most at risk. Healthcare providers who place the catheter may also be affected.
Check for the product code 5913350, 16F straight, 35cm length. The catheter was sold with lot number RECZ0711 and expires September 30, 2020.
Verify the product code 5913350, 16F straight, 35cm length, and lot number RECZ0711.
The recall is due to a risk of tunneler tip breakage during placement, which could cause complications. Use only the recalled model until the remedy is applied.
The recall record does not specify a remedy, so check with Bard for guidance on next steps.
Look for the product code 5913350, 16F straight, 35cm length, and lot number RECZ0711.
We’ve drafted a message you can send Bard to request your refund or repair — edit it as you like.
Subject: Recall Z-2380-2019 — Bard Bard Hello, I own a Bard that is covered by recall Z-2380-2019 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.
