ConvaTec recalls FilterFlow Suction Handle CH24 (20 per unit) used in orthopedic surgery due to potential sterile packaging breach. Affected units have specific lot codes and product codes.
An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
ConvaTec is recalling FilterFlow Suction Handles CH24 used in orthopedic surgery because their sterile packaging might be breached. This could risk infection during surgery if the device isn't properly sterilized.
The packaging might not maintain sterility properly during handling or storage. If the sterile barrier is breached, the device could become contaminated, increasing infection risk during surgery.
Orthopedic surgeons and surgical teams using the FilterFlow Suction Handle CH24 in procedures. Those with the specific lot codes (176482, 189027) or product code 504159 are most at risk.
Check for lot codes 176482 or 189027 on the packaging. The product code is 504159. This device is sold in sets of 20 per sales unit for orthopedic surgery.
Look for lot codes 176482 or 189027 and product code 504159 on the packaging.
The recall states there's a potential for sterile packaging breach, but the device itself is designed for orthopedic surgery. Affected units should be checked for lot codes.
The recall record does not specify a remedy or action for affected units. Check the product details to see if you have the affected lot codes.
Check for lot codes 176482 or 189027 and product code 504159 on the packaging. This device is sold in sets of 20 per sales unit for orthopedic surgery.
We’ve drafted a message you can send ConvaTec to request your refund or repair — edit it as you like.
Subject: Recall Z-1038-2019 — ConvaTec ConvaTec Hello, I own a ConvaTec that is covered by recall Z-1038-2019 from ConvaTec. 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.
