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18PR - Class A Complete - Poly Red
Certified Safety Manufacturing, Inc. · Model K616-061 · UDI-DI 00766588160610
10
510(k) clearances
10
Adverse events
4
Recalls
174
Facilities
Description
18PR - Class A Complete - Poly Red
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-11-15 | MEDLINE INDUSTRIES, LP - Northfield | Medline 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 |
| 2017-03-03 | Covidien LLC | Product sterility is compromised due to breach of sterile barrier |
| 2017-03-03 | Covidien LLC | Product sterility is compromised due to breach of sterile barrier |
| 2017-03-03 | Covidien LLC | Product sterility is compromised due to breach of sterile barrier |
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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.