FDA Recall D-0643-2022
CooperSurgical, Inc · North Tonawanda, NY
Class I — life-threatening Terminated 367 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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 51285-204-01
Reason for recall
Non-sterility
Recall record
- Recall number
D-0643-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- US Nationwide
- Recall initiated
- 2022-02-04
- Classified by FDA Center
- 2022-03-01
- FDA published
- 2022-02-23
- Terminated
- 2023-02-06
- Recalling firm
- CooperSurgical, Inc
- Firm location
- North Tonawanda, NY