The Recall Desk
HighFDA (Devices)·Z-2378-2021·Announced 2021-09-08

Baxter PrismaFlex Dialysis Tubing Sets Recalled Due to Sterilization Failure

Baxter PrismaFlex dialysis tubing sets are being recalled because products labeled sterile may not have been properly sterilized due to sterilization contractor failures and data integrity issues.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall involving sterile medical device where products labeled sterile may not be sterilized. Although this poses significant risk of harm through infection for dialysis patients, no illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products without reported injuries are scored as High (3).

Plain-English summary

Baxter Healthcare Corporation is recalling specific lots of Baxter PrismaFlex dialysis tubing sets, used with Prismafl or PrisMax control units for continuous fluid management and renal replacement therapies. Approximately 64,275 units were distributed nationwide.

The recall was initiated because products labeled as sterile may not have been properly sterilized. The sterilization contractor, Steril Milano, observed nonconformances in the sterilization process that were not reported to Baxter. Additionally, data was manipulated to appear conforming when it was not. This creates a significant risk that the products may be contaminated.

Patients who use these dialysis tubing sets should contact their healthcare provider immediately to determine if they have been affected and to discuss whether replacement or alternative supplies are needed. Healthcare facilities should verify which lots are in stock against the FDA recall list and implement appropriate actions to protect patient safety.

The recalled product

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 SET) f) 955467 (M 150 SET) g) 955468 (ST 100 SET) h) 955595 (M 100 SET) i) 955596 (ST 150 SET) Used with Prismafl
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Dialysis Equipment
Hazard
Affected units
64,275

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · sterility failure

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