CooperSurgical recalls Retractor System Elastic Stays (parts 3314-lG, 3316-lG, 3550-lG) due to possible compromised sterile pouch seals increasing infection risk. Affected lots include 244660, 245964, 250426, 251395, 244667, 244883, 244884, 245603, 245973, 246138, and 248871.
There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection.
CooperSurgical is recalling Retractor System Elastic Stays (parts 3314-lG, 3316-lG, 3550-lG) because the sterile pouch seals might be compromised, increasing infection risk during medical procedures. This affects specific production lots sold to hospitals and surgical centers.
The sterile pouch seals on these medical devices might become compromised, allowing contaminants to enter and increase the risk of infection during surgical procedures. This is a potential issue with the packaging integrity of the single-use device.
Hospitals and surgical centers that purchased the recalled Retractor System Elastic Stays (parts 3314-lG, 3316-lG, 3550-lG) from specific production lots. Medical staff using these devices during procedures are at risk of infection if the seal is compromised.
Check for the product name 'Retractor System Elastic Stays' with part numbers 3314-lG, 3316-lG, or 3550-lG. Affected lots include 244660, 245964, 250426, 251395, 244667, 244883, 244884, 245603, 245973, 246138, and 248871.
Identify the lot number on the device packaging to determine if it is one of the affected lots: 244660, 245964, 250426, 251395, 244667, 244883, 244884, 245603, 245973, 246138, or 248871.
The recall states there is a possibility that the seal of the sterile pouch may be compromised, increasing the risk of infection during medical procedures.
The official notice does not specify which hospitals should contact CooperSurgical.
The official notice does not specify action steps for medical staff beyond checking the lot number.
We’ve drafted a message you can send CooperSurgical to request your refund or repair — edit it as you like.
Subject: Recall Z-3278-2018 — CooperSurgical CooperSurgical Hello, I own a CooperSurgical that is covered by recall Z-3278-2018 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.
