Prismaflex ST Set: ST60 (product code 107643), ST100… recallZ-0084-2023 · Baxter Healthcare Corporation · initiated Sep 14, 2022

Why it was recalled

Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight restrictions.

FDA root cause category: Error in labeling

What the company is doing

Baxter sent an Urgent Medical Device Correction notice to its direct consignees by USPS on 09/14/2022. The notice explained the Estonian translation issue and requested that the following actions be taken by consumers: 1. Use of the Prismaflex HF20 set should be restricted to patients with a body weight greater than 8kg (18lb). Use of the Prismaflex M60 and ST60 sets should be restricted to patients with a body weight greater than 11kg (24lb). Use of the Prismaflex M100, ST100, M150, ST150, HF1000 and HF1400 sets should be restricted to patients with a body weight greater than 30kg (66lb). 2. Customers who are not referring to the Estonian IFU should continue to follow the IFU instructions in their language. 3. If you received this communication directly from Baxter, please acknowledge receipt by responding on our customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com/. 4. If you purchased this product from a distributor, please note that responding via the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to the supplier according to their instructions. 5. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them. 6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers of this Urgent Medical Device Correction in accordance with your customary procedures and check the associated box on the customer portal.

Recall details

Recall number

Z-0084-2023

Status

Open, Classified

Initiated by the company

Sep 14, 2022

Posted by the FDA

Oct 12, 2022

Recalling firm

Baxter Healthcare Corporation

Quantity

1,068,560 devices

Product code

KDI

FDA submissions

K212216

Distribution

US Nationwide

Product description

Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ST150 (product code 107640). For use in providing continuous fluid management and renal replacement therapies.

Other devices under the same FDA submission

3 devices cleared under K212216 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• PRISMAFLEX SET 107640US

  Gambro Industries · Dialyzer, high permeability with or without sealed dialysate system
  1 recall26 reports
• PRISMAFLEX SET 107636US

  Gambro Industries · Dialyzer, high permeability with or without sealed dialysate system
  1 recall9 reports
• PRISMAFLEX SET 107643US

  Gambro Industries · Dialyzer, high permeability with or without sealed dialysate system
  1 report

Other products in the same recall event

The FDA groups related products into one recall event (event 90841).

• Z-0081-2023 · Open, Classified
  Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in providing continuous fluid management and renal replacement therapies.
• Z-0082-2023 · Open, Classified
  Prismaflex M Set: M150 (product code 109990). For use in providing continuous fluid management and renal replacement therapies.
• Z-0083-2023 · Open, Classified
  Prismaflex HF Set: HF1000 (product code 107140), HF1400 (product code 107142). For use in providing continuous fluid management and renal replacement therapies.
• Z-0085-2023 · Open, Classified
  Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies.