CooperSurgical recalls H/S Catheter Set FR 5 Model 61-4005S for potential detachment during procedures, causing delays. Affected units may have incorrect bonding materials.
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 a specific catheter set used in gynecological procedures because faulty bonding could cause parts to detach, delaying medical treatments. This poses a risk during critical procedures where timely intervention is needed.
The catheter set uses incorrect bonding material during assembly, which can cause components to detach. This detachment might lead to broken parts or leaks, delaying the medical procedure and potentially affecting patient care.
Healthcare providers using this catheter set for hysterosalpingography or hysterosonography procedures are most at risk. Patients undergoing these specific gynecological tests may also be affected.
Check for the model number 61-4005S on the catheter set. The product was sold for use in hysterosalpingography or hysterosonography procedures to detect uterine issues.
Look for the model number 61-4005S on the catheter set to confirm if it is affected.
The catheter set uses incorrect bonding material during assembly, which can cause components to detach, leading to delays in medical procedures.
The recall record does not specify a remedy, so check the product details to confirm if it is affected.
The recall states that detachment could delay procedures, but does not mention serious injury risks.
We’ve drafted a message you can send CooperSurgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0504-2024 — CooperSurgical CooperSurgical Hello, I own a CooperSurgical that is covered by recall Z-0504-2024 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.
