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Baxter Healthcare Corporation Recall 88351

Description: Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.

Baxter Healthcare Corporation Recall 88351 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2379-2021
Event ID88351
Event DescriptionBaxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
Product TypeDevices
DistributionUS Nationwide distribution.
Quantity1976 units
Recall ReasonProducts labeled as sterile were distributed, but may not have been sterilized. Baxter confirmed Steril Milano observed nonconformances that were not reported to Baxter Data was manipulated to appear to be conforming
Device Classification20210908
Device Code InfoLot Numbers: 20B2330M
Center Classification Date20210827
Recall Initiation Date20210722
Recalling FirmBaxter Healthcare Corporation
Initial Notification Letter
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