Fenwal Recalls Amicus Exchange Kits Due to Centrifuge Pack Leaks
Fenwal Inc is recalling 2,466 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 that poses a risk of harm (blood leak) during procedures, but the source text does not report any 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 2,466 units of Amicus Exchange Kits. These kits are intended for use in the collection of blood components and mononuclear cells. The recall affects specific lots with batch numbers FA20F08147, FA20H12145, and FA20J27157.
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 when using therapeutic protocols only.
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, and NY. Users should stop using the affected kits and contact Fenwal Inc for further instructions.
The recalled product
- Product
- Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.
- Manufacturer
- Fenwal Inc
- Category
- Medical Device — Apheresis Kits
- Hazard
- Affected units
- 2,466
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 (5)
- Product Code X6R2339
- UDI: 04086000100151
- Batch Numbers FA20F08147 (Exp. 06/07/2022)
- FA20H12145 (Exp. 08/11/2022)
- FA20J27157 (Exp. 10/26/2022)
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
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