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PC
Allied Medical, LLC · Model 55-01-0025 · UDI-DI 00026072025307
5
510(k) clearances
206
Adverse events
7
Recalls
26
Facilities
Description
CARBOLIME,12 CANISTERS
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-08-05 | Armstrong Medical Services Limited | Some devices may be associated with high and unexpected resistance to gas flow during clinical use, impacting or preventing adequate ventilation of an anaesthetised patient, which |
| 2010-10-20 | Darex Container Products Div of W.R. Grace & Co. | Pre-Pak units of SODASORB CO2 absorbent manufactured prior to August 2010 may have missing or illegible expiration dates and/or batch numbers. |
| 2010-10-20 | Darex Container Products Div of W.R. Grace & Co. | Pre-Pak units of SODASORB CO2 absorbent manufactured prior to August 2010 may have missing or illegible expiration dates and/or batch numbers. |
| 2010-08-12 | Allied Healthcare Products Inc | The granules do not absorb as long as expected in the anesthesia machines |
| 2005-03-31 | Darex Container Products Div of W.R. Grace & Co. | Both lots were found to be out of specification due to an elevated level of small particles (fines). |
| 2003-02-11 | Darex Container Products Div of W.R. Grace & Co. | Contaminated with epoxy chips. |
| 2003-02-11 | Darex Container Products Div of W.R. Grace & Co. | Contaminated with epoxy chips. |
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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.