CooperSurgical recalls PARAGARD T380A intrauterine copper contraceptives due to non-sterility risk. One unit per carton with insertion tube and white rod is affected. No remedy specified in official notice.
Non-sterility
CooperSurgical has recalled one unit per carton of PARAGARD T380A intrauterine copper contraceptives because of a non-sterility hazard. This recall affects specific units sold with an insertion tube and solid white rod. The hazard means the product may not be sterile, which could lead to infections. No remedy is stated in the official recall notice.
The product may not be sterile, which could lead to infections during use. This non-sterility hazard is related to the manufacturing process of the intrauterine device.
Women who have received a PARAGARD T380A intrauterine copper contraceptive with an insertion tube and solid white rod are affected. Those who have used this specific product are at risk of non-sterility.
Check for PARAGARD T380A with an insertion tube and solid white rod in a Tyvek polyethylene pouch. The product is sold with a specific lot number (517001) and expiration date (1/2024).
Look for PARAGARD T380A with an insertion tube and solid white rod in a Tyvek polyethylene pouch.
The official recall notice does not specify any remedy.
The product may not be sterile, which could lead to infections.
Check for PARAGARD T380A with an insertion tube and solid white rod in a Tyvek polyethylene pouch. The product has lot number 517001 and expires 1/2024.
We’ve drafted a message you can send CooperSurgical to request your refund or repair — edit it as you like.
Subject: Recall D-0643-2022 — CooperSurgical CooperSurgical Hello, I own a CooperSurgical that is covered by recall D-0643-2022 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.
