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HomeCertified Safety Manufacturing, Inc. › OTS - Class B & Arc Flash Trauma - Hawke Bag

OTS - Class B & Arc Flash Trauma - Hawke Bag

Certified Safety Manufacturing, Inc. · Model K616-032 · UDI-DI 00766588160320

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10
510(k) clearances
10
Adverse events
4
Recalls
175
Facilities

Description

OTS - Class B & Arc Flash Trauma - Hawke Bag

Recalls

DateFirmReason
2023-11-15MEDLINE INDUSTRIES, LP - NorthfieldMedline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile
2017-03-03Covidien LLCProduct sterility is compromised due to breach of sterile barrier
2017-03-03Covidien LLCProduct sterility is compromised due to breach of sterile barrier
2017-03-03Covidien LLCProduct sterility is compromised due to breach of sterile barrier

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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.