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U.S. Department of Health and Human Services

Class 2 Device Recall LB53 Sterile Light Handle Cover

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 Class 2 Device Recall LB53 Sterile Light Handle Coversee related information
Date Initiated by FirmMarch 17, 2023
Date PostedApril 28, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1475-2023
Recall Event ID 92040
Product Classification Light, surgical, accessories - Product Code FTA
ProductSteris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including disposable surgical light handle covers are designed to fit over surgical light handles for sterile surgeon control. REF: LB53
Code Information GTIN number: 00724995150136 Lot Numbers: 9604187 / 9604187A 9604188 / 9604188A 9604189 / 9604189A 9604190 / 9604190A 9604191 / 9604191A 9799082 / 9799082A 9799083 / 9799083A 9799084 / 9799084A 9799085 / 9799085A 9799086 / 9799086A 9799087 / 9799087A 9799088 / 9799088A 9799089 / 9799089A 9799090 / 9799090A 9799091 / 9799091A 9799092 / 9799092A 9799093 / 9799093A 9799094 / 9799094A 9799095 / 9799095A 9799096 / 9799096A 9799097 / 9799097A 9799098 / 9799098A 9799099 / 9799099A 9799100 / 9799100A 9799101 / 9799101A 9799102 / 9799102A 9799103 / 9799103A 9799104 / 9799104A 9799105 / 9799105A 9799106 / 9799106A 9799107 / 9799107A 9799108 / 9799108A
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 Commerce1,358,520 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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