ZOLL recalls SOLEX 7 Intravascular Heat Exchange Catheter Kit with central venous infusion due to potential leaks from catheter or start-up kit tubing. All lots affected.
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
ZOLL is recalling its SOLEX 7 Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities because of potential leaks from the catheter or start-up kit tubing. This could lead to complications if the leaks cause fluid or medication to escape improperly.
The catheter or start-up kit tubing may leak, potentially causing fluid or medication to escape from the bloodstream. This could lead to improper treatment or complications if the leak occurs during use.
Healthcare professionals using the SOLEX 7 catheter kit for intravenous treatments are most at risk. The recall affects all units sold with the specific model and lot numbers.
Check for the model number SL-2593AE on the kit packaging. The product is sold with the lot number (00)849111075312 and is labeled as 'HEPARIN COATED, Sterile EO, Rx Only'.
Inspect the catheter and start-up kit tubing for signs of leakage after use.
Yes, all units sold with the model number SL-2593AE are affected.
The recall does not specify a remedy, so check for leaks and contact ZOLL for further guidance.
The recall mentions potential leaks but does not specify a risk of serious injury, so the danger level is low risk.
We’ve drafted a message you can send ZOLL to request your refund or repair — edit it as you like.
Subject: Recall Z-0043-2022 — ZOLL ZOLL Hello, I own a ZOLL that is covered by recall Z-0043-2022 from ZOLL. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
