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ESTEEM SYNERGY
CONVATEC, PURCHASING DEPARTMENT · Model 411639 · UDI-DI 00768455105908
6
510(k) clearances
2,020
Adverse events (1 deaths)
5
Recalls
49
Facilities
Description
Little Ones® Two-Piece Adhesive Coupling Technology? Closed End Pouch With Filter. Opaque. For Children Over 10Lbs.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-08-16 | ConvaTec, Inc | impaired functionality of the release liner |
| 2022-08-16 | ConvaTec, Inc | impaired functionality of the release liner |
| 2022-08-16 | ConvaTec, Inc | impaired functionality of the release liner |
| 2022-08-16 | ConvaTec, Inc | impaired functionality of the release liner |
| 2010-09-17 | Convatec Inc. | Mislabeled: the market units were incorrectly labeled as # 125339 ActiveLife Drainable Pouch 25 mm; the product inside was actually ActiveLife Pouch Small Tan 32 mm, ICC # 125333. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.