The Recall Desk
HighFDA (Devices)·Z-0081-2023·Announced 2022-10-19

Prismaflex M Set Recall for Mistranslated Weight Restriction Instructions

Baxter Healthcare is recalling Prismaflex M Sets (524,376 devices nationwide) due to a mistranslation in instructions for use that provides contradictory patient body weight restrictions for renal replacement therapy.

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: This is an FDA Class II recall involving contradictory labeling on a critical patient parameter (body weight restrictions) for devices used in renal replacement therapy. While no injuries or illnesses have been reported, the risk of harm is present due to potential for improper device use from contradictory instructions.

Plain-English summary

Baxter Healthcare Corporation is recalling the Prismaflex M Set, which includes two product variants: the M60 (product code 106696) and M100 (product code 106697). These devices are used for continuous fluid management and renal replacement therapies. Approximately 524,376 devices are affected and were distributed nationwide in the United States. All lot codes are included in this recall.

The recall was issued due to a mistranslation in the device's Instructions for Use (IFU). Specifically, the Estonian-language text contains a mistranslation that provides contradictory information regarding patient body weight restrictions. This contradictory guidance could lead healthcare providers to make improper treatment decisions based on conflicting instructions.

Healthcare facilities and providers using these devices should review the recall notice and follow any corrected instructions or guidance from Baxter Healthcare. The FDA has classified this as a Class II recall. Consult the official FDA recall documentation (Z-0081-2023) or contact Baxter Healthcare for further guidance.

The recalled product

Product
Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in providing continuous fluid management and renal replacement therapies.
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Renal Replacement Therapy
Hazard
  • mistranslation
  • contradictory-instructions
  • weight-restriction-error

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 (3)

  • UDI: 07332414064549 (product code 106696)
  • 07332414064556 (product code 106697)
  • All lot codes

Distribution

Distributed nationwide across the United States.

Related recalls

Same category