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PleurX

CAREFUSION 2200, INC · Model 50-7290 · UDI-DI 10885403193545

DWMPNG Prescription
10
510(k) clearances
1,122
Adverse events (24 deaths)
3
Recalls
29
Facilities

Description

PleurX Procedure Pack

Recalls

DateFirmReason
2022-05-25Mckesson Medical-Surgical Inc. Corporate OfficeFacility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0
2014-10-20Pfm Medical IncPFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
2014-10-20Pfm Medical IncPFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.

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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.