Baxter PrismaFlex recall
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…
Why was Baxter PrismaFlex 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- 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…
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 64275 units
- Distribution
- US Nationwide distribution.
- Recall date
- September 8, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)