Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
Reported: March 22, 2023 Initiated: February 14, 2023 #Z-1255-2023
Product Description
Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
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.
Details
- Recalling Firm
- Fenwal Inc
- Units Affected
- 6,564 units
- Distribution
- Nationwide distribution. International distribution to France, Korea, Taiwan, Colombia, India, Brazil, Germany, Canada.
- Location
- Lake Zurich, IL
Frequently Asked Questions
What product was recalled? ▼
Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform. Recalled by Fenwal Inc. Units affected: 6,564 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 22, 2023. Severity: Moderate. Recall number: Z-1255-2023.
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