Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables (disposable, sing
Summary
The FDA issued a Class II for Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -St by Steris Corporation. Reason: Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the ster.
Details
Source
Device Recall
External ID
Z-1476-2023
Action Date
2023-05-10
Status
Ongoing
Category
device
Product Description
Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables (disposable, single use) used to drape the lighthandle of STERIS surgical lighting systems for the purpose of maintaining a sterile surgical environment. REF: LB44
Lot/Code Info: GTIN number: 00724995192570 Lot Numbers: 9943616 / 9943616A 9943617 / 9943617A 9943619 / 9943619A 9943620 / 9943620A 9959650 / 9959650A 9959651 / 9959651A
Quantity Affected: 263,280 covers
Reason for Recall
Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient
Distribution
Worldwide - US Nationwide distribution including Puerto Rico and the countries of Canada, Australia.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-17
Company
Mentor, OH
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 168 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Steris Corporation has 71 FDA actions in our database, including 28 recalls and 43 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 (Steris Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Steris Corporation have FDA actions?
Steris Corporation has 71 FDA actions in our database, including 28 recalls and 43 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1476-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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