—#188475

Product

Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.

FDA product code: KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K042938
Affected lot / code info: Lot Numbers: 20B2330M

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

Root cause (FDA determination)

Vendor change control

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2021-07-22
Terminated: 2024-01-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188475. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.