Summary
The FDA issued a Class II for XVIVO Organ Chamber REF 19020 by XVIVO PERFUSION AB. Reason: The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed..
Details
Source
Device Recall
External ID
Z-1212-2022
Action Date
2022-06-08
Status
Terminated
Category
device
Product Description
XVIVO Organ Chamber REF 19020
Lot/Code Info: Model Number: 19020 Lot Numbers/UDI Codes: LOT: 13801, UDI: (01)07350069520074(17)240930(10)13801 LOT: 13802, UDI: (01)07350069520074(17)240930(10)13802 LOT: 13803, UDI: (01)07350069520074(17)240930(10)13803 LOT: 13804, UDI: (01)07350069520074(17)240930(10)13804 LOT: 13805, UDI: (01)07350069520074(17)240930(10)13805 LOT: 13806, UDI: (01)07350069520074(17)240930(10)13806
Quantity Affected: 80 devices
Reason for Recall
The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.
Distribution
U.S.: CA, FL, MA, NC, NY, OH, PA, and TX O.U.S.: Austria, Canada, France, Ireland, Italy, and the Netherland
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-08
Company
Goteborg, N/A
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 184 device recalls issued in the same week, part of 403 device-related FDA actions this month.
XVIVO PERFUSION AB has 2 FDA actions in our database, including 1 recall and 1 clearance.
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 (XVIVO PERFUSION AB) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does XVIVO PERFUSION AB have FDA actions?
XVIVO PERFUSION AB has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1212-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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