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ATRAMAT
Internacional Farmacéutica, S.A. de C.V. · Model ACERO · UDI-DI 07500142047367
1
510(k) clearances
936
Adverse events (7 deaths)
6
Recalls
74
Facilities
Description
ATRAMAT STAINLESS STEEL SURGICAL SUTURE USP 1 EP 4, 4 X 45 CM NEEDLE SR-26 PREMIUM REGULAR TAPER POINT 26 MM 1/2 CIRCLE ACERO INOXIDABLE USP 1, 4 X 45 CM AGUJA SR-26 AHUSADA REGULAR PREMIUM 26 MM 1/2 CIRCULO
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0 |
| 2019-04-19 | Ethicon, Inc. | Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot |
| 2019-04-19 | Ethicon, Inc. | Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot |
| 2014-03-11 | Teleflex Medical | Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use. |
| 2014-03-11 | Teleflex Medical | Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use. |
| 2014-03-11 | Teleflex Medical | The products are being recalled because they did not meet minimum diameter requirements. |
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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.