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Dsm19 5-0 Pl Gut 18"/45cm

Surgical Specialties México, S. de R.L. de C.V. · Model B0500N · UDI-DI 00848782011995

GAL Prescription
10
510(k) clearances
2,489
Adverse events (5 deaths)
5
Recalls
70
Facilities

Description

Dsm19 5-0 Pl Gut 18"/45cm

Recalls

DateFirmReason
2023-03-01Covidien, LPMedtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspec
2023-03-01Covidien, LPMedtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspec
2023-03-01Covidien, LPMedtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspec
2019-02-04CP Medical IncPotential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result.
2015-05-08Ethicon, Inc.Ethicon Fast Absorbing Surgical Gut (Plain) Suture is being recalled because the labeling on the box and foil are incomplete.

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Data 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.