Baxter Healthcare Corporation Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
Brand
Baxter Healthcare Corporation
Lot Codes / Batch Numbers
Lot Numbers: 20B2330M
Products Sold
Lot Numbers: 20B2330M
Baxter Healthcare Corporation is recalling Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units due to Products labeled as sterile were distributed, but may not have been sterilized. Baxter confirmed Steril Milano observed nonconformances that were not. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026