CooperSurgical recalls sterile cervical dilator sets with potentially compromised pouch seals. Affected units from specific lot number may pose infection risk if used improperly.
The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators.
CooperSurgical is recalling sterile cervical dilator sets that may have compromised pouch seals. This could lead to infection if the pouch seal fails during use. The recall affects specific lot numbers sold in South Korea.
The sterile pouch seal could be compromised, potentially allowing contamination. If the pouch seal fails during use, the device might become contaminated and cause infection. This risk is specific to the affected lot numbers.
Healthcare providers using the sterile cervical dilator sets for medical procedures. Patients undergoing procedures with these devices may be at risk if the pouch seal fails.
Check for the product name 'CooperSurgical Dilator/Sound Set', lot number 257589, and the model number MX21. The product was made in South Korea and sold as a sterile/EO device.
Verify the lot number and model number on the sterile pouch to confirm if it's affected.
The recall indicates a potential risk with specific lot numbers, but the product is generally safe if the pouch seal is intact.
Check the lot number and model number to see if it's affected; if so, contact CooperSurgical for guidance.
The recall record does not specify a replacement process or remedy.
We’ve drafted a message you can send CooperSurgical to request your refund or repair — edit it as you like.
Subject: Recall Z-2112-2020 — CooperSurgical CooperSurgical Hello, I own a CooperSurgical that is covered by recall Z-2112-2020 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.
