Summary
The FDA issued a Class II for Spectrum Medical Quantum Standard heat exchanger by QURA S.R.L.. Reason: Product labeled as sterile may not have been adequately sterilized. In addition, these devices were imported to the US distributor, but the devices ar.
Details
Source
Device Recall
External ID
Z-2277-2021
Action Date
2021-08-18
Status
Terminated
Category
device
Product Description
Spectrum Medical Quantum Standard heat exchanger
Lot/Code Info: Batch Numbers: B000129, C000415, C000416, C000417
Quantity Affected: 1088 units
Reason for Recall
Product labeled as sterile may not have been adequately sterilized. In addition, these devices were imported to the US distributor, but the devices are not 510(k) cleared in the US.
Distribution
US Nationwide distribution in the state of South Carolina.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-03-22
Company
Mirandola, 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 183 device recalls issued in the same week, part of 403 device-related FDA actions this month.
QURA S.R.L. has 13 FDA actions in our database, including 1 recall and 12 clearances.
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 (QURA S.R.L.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does QURA S.R.L. have FDA actions?
QURA S.R.L. has 13 FDA actions in our database, including 1 recall and 12 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2277-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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