Reported Sep 8, 2021 · Terminated
Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307…
Baxter Healthcare Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625
Is this the product you have?
9 of 9 products
| # | Product as published |
|---|---|
| 1 | 106696 (M 60 SET) |
| 2 | 106697 (M 100 SET) Expansion |
| 3 | 107144 (TPE2000 SET) |
| 4 | 115307 (M 150 SET) |
| 5 | 115309 (ST 100 SET) |
| 6 | 955467 (M 150 SET) |
| 7 | 955468 (ST 100 SET) |
| 8 | 955595 (M 100 SET) |
| 9 | 955596 (ST 150 SET) Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies. |
- Lot codes and dates
8 of 8 products
Products covered by this recall # Product as published 1 Lot Numbers: 20B2323M, 20B2328M (expanded to include 20B2326M) Expansion: c) 107144 2 Lot Number 20B2325M d) 115307 3 Lot Number 20B2321M e) 115309 4 Lot Number 20B2310M and 20F0201 f) 955467 5 Lot Numbers 20A2604M, 20A2606M, 20A2607M, 20A2608M, 20B2331M, 20B2332M, 20B2333M, 20B2334M, 20B2335M, 20B2336M, 20B2347M, 20A2605M g) 955468 6 Lot Numbers 20A2602M, 20A2603M, 20B2308M, 20B2311M, 20B2312M, and 20B2324M h) 955595 7 Lot Numbers 20A2609M, 20A2610M, 20B2337M, 20B2338M, 20B2339M, 20B2340M, 20B2341M, 20B2342M, 20B2343M, 20B2344M, 20B2345M, and 20B2346M i) 955596 8 Lot Numbers 20A2601M, 20B2302M, and 20B2309M - Amount recalled
- 64275 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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