Recall Z-1475-2023 ยท FTA Light, Surgical, Accessories
Steris Corporation
Steris 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
| Date | Apr 28, 2023 (initiated Mar 17, 2023) |
| Status | Open, Classified |
| 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 sterile field which could result in an injury to the patient |
| Root cause | Under Investigation by firm |
| Action | 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 coor |
| Quantity | 1,358,520 covers |
| Distribution | Worldwide - US Nationwide distribution including Puerto Rico and the countries of Canada, Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.