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Baxter Healthcare Corporation Recall 88351

Description: Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307 (M 150 SET) e) 115309 (ST 100 SET) f) 955467 (M 150 SET) g) 955468 (ST 100 SET) h) 955595 (M 100 SET) i) 955596 (ST 150 SET) 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-2378-2021
Event ID88351
Event DescriptionBaxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307 (M 150 SET) e) 115309 (ST 100 SET) f) 955467 (M 150 SET) g) 955468 (ST 100 SET) h) 955595 (M 100 SET) i) 955596 (ST 150 SET) Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
Product TypeDevices
DistributionUS Nationwide distribution.
Quantity64275 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 Infoa) 106696, Lot Numbers: 20B2329M b) 106697, Lot Numbers: 20B2323M, 20B2328M (expanded to include 20B2326M) Expansion: c) 107144, Lot Number 20B2325M d) 115307, Lot Number 20B2321M e) 115309, Lot Number 20B2310M and 20F0201 f) 955467, Lot Numbers 20A2604M, 20A2606M, 20A2607M, 20A2608M, 20B2331M, 20B2332M, 20B2333M, 20B2334M, 20B2335M, 20B2336M, 20B2347M, 20A2605M g) 955468, Lot Numbers 20A2602M, 20A2603M, 20B2308M, 20B2311M, 20B2312M, and 20B2324M h) 955595, Lot Numbers 20A2609M, 20A2610M, 20B2337M, 20B2338M, 20B2339M, 20B2340M, 20B2341M, 20B2342M, 20B2343M, 20B2344M, 20B2345M, and 20B2346M i) 955596, Lot Numbers 20A2601M, 20B2302M, and 20B2309M
Center Classification Date20210827
Recall Initiation Date20210722
Recalling FirmBaxter Healthcare Corporation
Initial Notification Letter
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