Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
Summary
The FDA issued a Class II for Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural by Fenwal Inc. Reason: Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the.
Details
Source
Device Recall
External ID
Z-1255-2023
Action Date
2023-03-22
Status
Ongoing
Category
device
Product Description
Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
Lot/Code Info: Product Code X6R2349; UDI: 04086000101950; Batch Numbers: FA22E23138, FA22F28168, FA22G28018, FA22H22225, FA22J28062, FA22K21065. 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.
Quantity Affected: 6,564 units
Reason for Recall
Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator.
Distribution
Nationwide distribution. International distribution to France, Korea, Taiwan, Colombia, India, Brazil, Germany, Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-14
Company
Lake Zurich, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 134 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Fenwal Inc has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Fenwal Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Fenwal Inc have FDA actions?
Fenwal Inc has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1255-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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