Fenwal Recalls Amicus Exchange Kits Due to Centrifuge Pack Leaks
Fenwal Inc is recalling 24 units of Amicus Exchange Kits because centrifuge packs may leak blood during therapeutic procedures.
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: The recall involves a medical device defect (blood leak) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Fenwal Inc is recalling 24 units of Amicus Exchange Kits. These medical devices are intended for use in the collection of blood components and mononuclear cells. The recall involves specific product codes and batch numbers: Product Code X6R2349, UDI 04086000101950, Batch Numbers FA20E25150 (Exp. 05/31/2022) and FA20I22142 (Exp. 09/30/2022).
The recall is due to a defect where centrifuge packs may leak blood during a procedure on the Amicus Separator using therapeutic protocols only. The leak can occur at the boot, elbow, or in the channel on the separation chamber of the centrifuge pack.
The affected units were distributed nationwide in the states of GA, TX, TN, MD, CA, KS, MN, MA, NM, NC, LA, CO, KY, NV, PA, UT, MI, NJ, IL, OH, and NY. Healthcare facilities and users should stop using the affected kits and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclear cells.
- Manufacturer
- Fenwal Inc
- Hazard
- Affected units
- 24
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)
- Product Code X6R2349
- UDI: 04086000101950
- Batch Numbers FA20E25150 (Exp. 05/31/2022) and FA20I22142 (Exp. 09/30/2022)
Distribution
Part of a larger recall action
This product is one of 3 recalled by Fenwal Inc 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 3 products in this recall →Related recalls
Same manufacturer · Fenwal Inc
See all →- HighMedical Device Apheresis Kit Recalled Due to Stress Leak Risk
FDA (Devices) · 2023-03-22
- HighAmicus MNC Apheresis Kit at Risk of Stress Leak in Centrifuge Packs
FDA (Devices) · 2023-03-22
- HighFenwal Recalls Amicus Exchange Kits Due to Centrifuge Pack Leaks
FDA (Devices) · 2021-04-14
- SevereFenwal Recalls Amicus MNC Apheresis Kits Due to Centrifuge Pack Leaks
FDA (Devices) · 2021-04-14
- SevereFenwal Recalls Vigilant Agilia and Volumat MC Agilia Infusion Pump Software
FDA (Devices) · 2019-08-21
Same hazard · blood leak
See all →- HighFresenius 5008X HDF Hemodialysis Blood Tubing Sets recalled for potential blood leaks
FDA (Devices) · 2025-06-25
- HighDialyzer Optiflux 160NRe recalled for potential internal blood leaks from cracked polyurethane
FDA (Devices) · 2025-01-15
- HighBaxter Revaclear 400 Dialyzers Recalled for Polyurethane Displacement
FDA (Devices) · 2022-12-28
- HighBaxter Revaclear 300 Dialyzers Recalled for Polyurethane Displacement
FDA (Devices) · 2022-12-28
- HighRevaclear 400 Dialyzers Recalled for Polyurethane Displacement Risk
FDA (Devices) · 2022-12-28