DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors
Summary
The FDA issued a Class II for DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors by DeRoyal Industries Inc. Reason: Procedure packs contained a recalled product..
Details
Source
Device Recall
External ID
Z-1668-2022
Action Date
2022-09-07
Status
Terminated
Category
device
Product Description
DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors
Lot/Code Info: NS CVR PREP PACK /89-6817.09; Lots 56391514 (exp 08/01/2023), 56926777 (exp 08/01/2023), 57103035 (exp. 08/01/2023); UDI-DI (GTIN): 00749756730938 NON-STERILE IR ADMISSION KIT / 89-8762.05; Lot 57104020 (exp 07/01/2023); UDI-DI (GTIN): 00749756883627
Quantity Affected: 1306 kits
Reason for Recall
Procedure packs contained a recalled product.
Distribution
US Nationwide distribution in the states of OH and TN.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-08-12
Company
Powell, TN
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 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.
DeRoyal Industries Inc has 183 FDA actions in our database, including 181 recalls and 2 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 (DeRoyal Industries Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DeRoyal Industries Inc have FDA actions?
DeRoyal Industries Inc has 183 FDA actions in our database, including 181 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1668-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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