Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables (disposable, single

FDA device recall Z-1476-2023 · posted 2023-04-28 · Open, Classified

Recall details

Recalling firm

Steris Corporation

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

Action taken

Steris 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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

FTA

Quantity affected

263,280 covers

Distribution

Worldwide - US Nationwide distribution including Puerto Rico and the countries of Canada, Australia.

Date initiated

2023-03-17

Date posted

2023-04-28

Location

Mentor, OH