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ATRAMAT
Internacional Farmacéutica, S.A. de C.V. · Model POLIPROPILENO · UDI-DI 07500142000232
1
510(k) clearances
19,686
Adverse events (226 deaths)
28
Recalls
110
Facilities
Description
ATRAMAT POLYPROPYLENE SURGICAL SUTURE BLUE USP 3-0 EP 2, 45 CM NEEDLE CE-24 REVERSE CUTTING 24 MM 3/8 CIRCLE POLIPROPILENO AZUL USP 3-0, 45 CM AGUJA CE-24 REVERSO CORTANTE 24 MM 3/8 CIRCULO
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-24 | Covidien, LP | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of v |
| 2026-06-24 | Covidien, LP | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of v |
| 2024-12-20 | Ethicon, LLC | Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could intr |
| 2024-12-20 | Ethicon, LLC | Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could intr |
| 2024-12-20 | Ethicon, LLC | Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could intr |
| 2022-12-02 | Covidien, LP | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact |
| 2022-12-02 | Covidien, LP | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact |
| 2018-05-07 | Ethicon, Inc. | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to caus |
| 2018-05-07 | Ethicon, Inc. | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to caus |
| 2018-05-07 | Ethicon, Inc. | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to caus |
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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.