Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; an
Summary
The FDA issued a Class II for Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION P by DeRoyal Industries Inc. Reason: The custom procedure packs contain light handle covers that have been recalled by another firm..
Details
Source
Device Recall
External ID
Z-1692-2023
Action Date
2023-06-14
Status
Ongoing
Category
device
Product Description
Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and (2) 89-10567.05, OB-OR C-SECTION PACK, Carilion Roanoke Memorial Hospital.
Lot/Code Info: (1) 89-10529.04 - lot 58700691, exp 11/1/2024, GTIN pack-00749756363334, case-50749756363339; (2) 89-10567.05 - lot 58700026, exp 12/1/2024, GTIN pack-00749756364300, case-50749756364305.
Quantity Affected: 23 cases (52 packs)
Reason for Recall
The custom procedure packs contain light handle covers that have been recalled by another firm.
Distribution
US Nationwide distribution in the state of VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-17
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 139 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-1692-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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