Agency classClass IIOur severity:Severe FDA (Devices)·Z-1343-2021·Announced 2021-04-14

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Hazard: blood-leak
structural-defect
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

Distributed nationwide across the United States.

The notice also names 22 states specifically:

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 →

Same manufacturer · Fenwal Inc

See all →

High
Medical Device Apheresis Kit Recalled Due to Stress Leak Risk
FDA (Devices) · 2023-03-22
High
Amicus MNC Apheresis Kit at Risk of Stress Leak in Centrifuge Packs
FDA (Devices) · 2023-03-22
High
Fenwal Recalls Amicus Exchange Kits Due to Centrifuge Pack Leaks
FDA (Devices) · 2021-04-14
High
Fenwal Recalls Amicus Exchange Kits Due to Centrifuge Pack Leaks
FDA (Devices) · 2021-04-14
Severe
Fenwal Volumat MC Agilia Infusion Pump Software Recall
FDA (Devices) · 2019-08-21

Same hazard · blood leak