Amicus Exchange Kit - Product Usage: intended for use in… recallZ-1344-2021 · Fenwal Inc · initiated Feb 25, 2021

Why it was recalled

Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols only. The defect is a blood leak at the boot, elbow, or in the channel on the separation chamber of the centrifuge pack.

FDA root cause category: Under Investigation by firm

What the company is doing

A Recall notification letter titled, "URGENT - Medical Device Recall Amicus MNC Apheresis/Exchange Disposable Kits" and form titled, Amicus Therapeutic Kits Customer Reply Form were sent to consignees on 02/25/2021 via Fed Ex Overnight Express. The consignee requested their customers to: 1) Discontinue use of the affected products immediately by checking their inventory and quarantining all affected product at their facility. They were also informed to contact Fresenius Kabi Customer Service at 800-333-6925, Prompt 1 for replacement kits to ensure additional procedures can continue. 2) Inform potential users of the product in their organization of this notification. 3) Based on the options listed below, complete the attached response form and return via the fax number, email address, or the enclosed Fed Ex envelope and return address. Option A: If there is no remaining inventory of the affected product complete the response form and return it to Fresenius Kabi. Option B: If the customer has affected product in inventory and wishes to return it: Contact Fresenius Kabi Customer Service at 800-333-6925, Prompt 1 and request to return the affected product. They will assist the customer with placing a replacement order at that time. Option C: If the customer has a small number of kits in inventory and are willing to destroy the product on Fresenius Kabis behalf: Contact Fresenius Kabi Customer Service at 800-333-6925, Prompt 1 to identify if the customer has product to be destroyed and require replacement. They will provide a certificate of destruction for completion. Once completed, the certificate should be returned to Fresenius Kabi and replacements will be sent. Customers may be in a position that no alternate Device is available and therefore choose to continue with the use of the affected Amicus MNC Apheresis kits or Amicus Exchange kits (Therapeutics kits). For such cases, the following actions should be put in place until replacement products a

Recall details

Recall number

Z-1344-2021

Status

Terminated

Initiated by the company

Feb 25, 2021

Recalling firm

Fenwal Inc

Quantity

2466 units

Product code

LKN

FDA submissions

K180615

Distribution

US Nationwide distribution in the states of GA, TX, TN, MD, CA, KS, MN, MA, NM, NC, LA, CO, KY, NV, PA, UT, MI, NJ, IL, MD, OH, NY, FL.

Product description

Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• AMICUS Exchange Kit X6R2339

  Fresenius Kabi AG · Separator, Automated, Blood Cell And Plasma, Therapeutic
  1 recall0 reports

Other devices under the same FDA submission

1 device cleared under K180615 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• AMICUS Exchange Kit - Therapeutics X6R2349

  Fresenius Kabi AG · Separator, Automated, Blood Cell And Plasma, Therapeutic
  2 recalls0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 87407).

• Z-1343-2021 · Terminated
  Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and mononuclear cells.
• Z-1345-2021 · Terminated
  Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclear cells.