CooperSurgical recalls H/S ELLI:5 FR Set for possible detachment during hysterosalpingography procedures. This could delay treatment. Affected units have specific serial numbers and model.
Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure
CooperSurgical is recalling its H/S ELLIPTOSPHERE CATH 5 FR Set used for hysterosalpingography procedures. The catheter may detach or break during use, causing delays in treatment. This is a safety issue for patients undergoing these procedures.
The catheter uses incorrect bonding material during assembly, which can cause parts to detach or break. This breakage may lead to delays in the procedure, potentially affecting patient care.
Patients undergoing hysterosalpingography or hysterosonography procedures are most at risk. Healthcare providers using this specific catheter set for uterine pathology detection may also be affected.
Check for model number 61-4005 and serial numbers 313121 or 313568. This set is used for hysterosalpingography procedures to detect uterine issues.
Verify the model number (61-4005) and serial numbers (313121, 313568) to confirm if your set is affected.
The model number is 61-4005.
The affected serial numbers are 313121 and 313568.
The catheter uses incorrect bonding material during assembly, which may cause parts to detach or break during use.
We’ve drafted a message you can send CooperSurgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0503-2024 — CooperSurgical CooperSurgical Hello, I own a CooperSurgical that is covered by recall Z-0503-2024 from CooperSurgical. 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.
