Fenwal Recalls Amicus MNC Apheresis Kits Due to Centrifuge Pack Leaks
Fenwal Inc is recalling specific lots of Amicus MNC Apheresis Kits because centrifuge packs may leak blood during therapeutic procedures.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a medical device that results in a blood leak, which poses a significant risk of injury or adverse health consequences.
Plain-English summary
Fenwal Inc is recalling 4,488 units of Amicus MNC Apheresis Kits - Double Needle. The recall affects specific product code X6R2326 and UDI 04086000100144, with batch numbers FA20E25234, FA20F23120, FA20I21268, and FA20J19246. These kits are intended for use in the collection of blood components and mononuclear cells.
The recall is due to a defect where centrifuge packs may leak blood at the boot, elbow, or in the channel on the separation chamber during a procedure on the Amicus Separator. This issue occurs specifically when using therapeutic protocols.
The affected products 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, NY, and FL. Healthcare facilities and users should stop using the affected lots and contact Fenwal Inc for further instructions.
The recalled product
- Product
- Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and mononuclear cells.
- Manufacturer
- Fenwal Inc
- Category
- Medical Device — Apheresis Kit
- Affected units
- 4,488
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 (6)
- Product Code X6R2326
- UDI: 04086000100144
- Batch Numbers FA20E25234 ((Exp. 05/31/2022)
- FA20F23120 (Exp. 06/30/2022)
- FA20I21268 (Exp. 09/30/2022)
- and FA20J19246 (Exp. 10/31/2022).
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.
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