Paragard T380A Intrauterine Contraceptive Device Recall for Non-Sterility
CooperSurgical, Inc is recalling 48,645 cartons of Paragard T380A intrauterine contraceptive devices nationwide due to non-sterility concerns. The voluntary recall affects Lot #517001 with expiration date 1/2024.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I recall. Although no specific illnesses or injuries are reported in the source text, the non-sterility of a device inserted into the body creates significant risk of serious infection or harm, qualifying it as Severe under the rubric's criterion for Class I recalls.
Plain-English summary
CooperSurgical, Inc is voluntarily recalling 48,645 cartons of Paragard T380A (intrauterine copper contraceptive) nationwide. The recall was initiated on February 4, 2022, following the identification of a non-sterility issue in Lot #517001, which expires in January 2024.
Each carton contains one contraceptive device packaged with an insertion tube and solid white rod in a Tyvek polyethylene pouch. The product is manufactured by Teva Women's Health Inc., a subsidiary of Teva Pharmaceuticals USA, Inc., located in North Wales, Pennsylvania (NDC 51285-204-01).
The non-sterility concern poses a potential risk of infection to users of the affected devices. Patients who received devices from this lot should consult their healthcare provider about the recall. The FDA classified this as a Class I recall, the most serious classification. The recall was terminated on February 6, 2023.
The recalled product
- Product
- PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an insertion tube and solid white rod in a Tyvek polyethylene pouch, Rx Only, Manufactured by Teva Women's Health Inc. a subsidiary of Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 51
- Manufacturer
- CooperSurgical, Inc
- Hazard
- non-sterility
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 517001
- Exp 1/2024
Distribution
Distributed nationwide across the United States.
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