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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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…
- Manufacturer
- CooperSurgical, Inc
- Affected units
- 48,645
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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