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U.S. Department of Health and Human Services

Class 2 Device Recall Amicus MNC Apheresis Kit

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  Class 2 Device Recall Amicus MNC Apheresis Kit see related information
Date Initiated by Firm February 14, 2023
Date Posted March 15, 2023
Recall Status1 Open3, Classified
Recall Number Z-1254-2023
Recall Event ID 91704
510(K)Number K180615  
Product Classification Separator, automated, blood cell and plasma, therapeutic - Product Code LKN
Product Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform
Code Information 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.
Recalling Firm/
Manufacturer		 Fenwal Inc
3 Corporate Dr Ste 300
Lake Zurich IL 60047-8930
For Additional Information Contact Matt Kuhn
847-550-5751
Manufacturer 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.
FDA Determined
Cause 2		 Process control
Action Fresenius Kabi notified customers on 02/14/2023 via FedEx overnight delivery. Customers were instructed to evaluate affected inventory on site for potential continued use according to the conditions in the letter, inform potential users of affected product within the facility and any customers if further distributed, complete and return the acknowledgment form, and report any issues.
Quantity in Commerce 1,614 units
Distribution Nationwide distribution. International distribution to France, Korea, Taiwan, Colombia, India, Brazil, Germany, Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LKN and Original Applicant = Fresenius Kabi USA LLC
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