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U.S. Department of Health and Human Services

Class 2 Device Recall LB44 NonSterile Light Handle Cover

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 Class 2 Device Recall LB44 NonSterile Light Handle Coversee related information
Date Initiated by FirmMarch 17, 2023
Date PostedApril 28, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1476-2023
Recall Event ID 92040
Product Classification Light, surgical, accessories - Product Code FTA
ProductSteris 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
Code Information GTIN number: 00724995192570 Lot Numbers: 9943616 / 9943616A 9943617 / 9943617A 9943619 / 9943619A 9943620 / 9943620A 9959650 / 9959650A 9959651 / 9959651A
Recalling Firm/
Manufacturer		 Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information ContactSAME
440-392-7601
Manufacturer 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
FDA Determined
Cause 2		Under Investigation by firm
ActionSteris issued Urgent Medical Device Recall Letter on 3/17/23 via FedEx. Letter states reason for recall, health risk and action to take: 1. Please immediately inspect your on-hand inventory for product affected by this recall. For the full list of lots affected by this recall, please reference Attachment A to this letter. 2. Please complete the Medical Device Recall Response Form included with this letter and destroy any remaining product in your inventory. If product was transferred to any other entities within your organization, please forward this recall notice accordingly. STERIS will coordinate shipment of replacement product upon receipt of the completed Recall Response Form. 3. Return the completed Recall Response Form via email to: Regulatory_Compliance@STERIS.com or via fax to (440) 392-8963. Users are reminded to report any adverse events via FDA s MedWatch Database should an event occur. If you have questions regarding this recall, please contact STERIS Customer Service at 1-800-548-4873, or email the RMA Team at HealthcareRMA@STERIS.com.
Quantity in Commerce263,280 covers
DistributionWorldwide - US Nationwide distribution including Puerto Rico and the countries of Canada, Australia.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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