Z-0082-2023Class II

Prismaflex M Set: M150 (product code 109990). For use in providing continuous fluid management and renal...

Name: Z-0082-2023 Prismaflex M Set: M150 (product code 109990). For use in providing continuous fluid management and renal...
Creator: Baxter Healthcare Corporation
Published: 2022-09-14
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2022-09-14 / Open, Classified / root cause: labeling and UDI

FDA source

Baxter Healthcare Corporation began a recall of Prismaflex M Set: M150 (product code 109990). For use in providing continuous fluid management and renal replacement therapies on 2022-09-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0082-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-14
Posted: 2022-10-12
Recalling firm: Baxter Healthcare Corporation
Product: Prismaflex M Set: M150 (product code 109990). For use in providing continuous fluid management and renal replacement therapies.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: 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.
Quantity in commerce: 334,932 devices
Distribution: US Nationwide
Product codes and lots: UDI 07332414090005; All Lot Codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0082-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0081-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-12
Z-0082-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-12
Z-0083-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-12
Z-0084-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-12
Z-0085-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-19	2022-10-12

Product code KDI

K080519Class IIPrismaflex M150 SetGambro Renal Products, Inc. / cleared 2008-06-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)