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.
Hazard
Products 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
What You Should Do
Remedy
The firm notified its consignees of the recall by letter on 07/22/2021. The letter explained the issue and requested the return of the affected product. Distributors were directed to notified their consignees.
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Products
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 S
- Brand
- Baxter Healthcare Corporation
- UPC
- a) 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
Units Affected
64275 units