The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1254-2023·Announced 2023-03-22

Amicus MNC Apheresis Kit at Risk of Stress Leak in Centrifuge Packs

Fenwal Inc is recalling certain batches of the Amicus MNC Apheresis Kit due to a potential for centrifuge packs to develop stress leaks. Affected units were distributed nationwide and internationally.

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 3/5 (High).

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: FDA Class II medical device recall with potential for equipment failure (stress leak). No illnesses or injuries have been reported; the hazard is theoretical. Per the rubric, recalls with theoretical hazards and no reported harm score at most 3.

Plain-English summary

Fenwal Inc is recalling specific batches of the Amicus MNC Apheresis Kit, a component of the Amicus Separator multiprocedural apheresis platform. The recall involves 1,614 units.

The U.S. Food and Drug Administration classified this as a Class II recall due to a potential for centrifuge packs in affected units to develop stress leaks.

Affected batches were distributed nationwide and internationally, including France, Korea, Taiwan, Colombia, India, Brazil, Germany, and Canada. The affected batch numbers are: FA22G25121, FA22H22134, FA22I26141, FA22J25225, and FA22J31074.

Healthcare facilities and medical professionals should verify whether any of their equipment uses these batch numbers and follow FDA guidance for this Class II recall.

The recalled product

Product
Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform
Manufacturer
Fenwal Inc
Category
Medical Device — Apheresis Equipment
Hazard
Affected units
1,614

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 (13)

  • Product Code X6R2326
  • UDI: 04086000100144
  • Batch Numbers: FA22G25121
  • FA22H22134
  • FA22I26141
  • FA22J25225
  • FA22J31074. The Lot number coding system is the following: FAXXYaabbc
  • FA = Haina (manufacturing / production unit)
  • XX = two digit year
  • Y= letter of the alphabet corresponding to the month
  • aa= day
  • bb= sequential number
  • c= check digit.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

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