Recall Z-0085-2023
Baxter Healthcare Corporation · initiated September 14, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies.
Codes / lots: UDI 07332414089443, All Lot Codes
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.
FDA-determined cause: Error in labeling
Action taken
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.
Details
- Recall number
- Z-0085-2023
- Initiated
- September 14, 2022
- Posted by FDA
- October 12, 2022
- Product code
- KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Quantity
- 29,764 devices
- Distribution
- US Nationwide
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0081-2023 Class II | Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in…Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian… | 09/14/2022Open, Classified |
| Z-0082-2023 Class II | Prismaflex M Set: M150 (product code 109990). For use in providing continuous fluid…Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian… | 09/14/2022Open, Classified |
| Z-0083-2023 Class II | Prismaflex HF Set: HF1000 (product code 107140), HF1400 (product code 107142). For use…Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian… | 09/14/2022Open, Classified |
| Z-0084-2023 Class II | Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ST150…Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian… | 09/14/2022Open, Classified |