Trulight 5000/3000 Surgical Light recall
Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical Lights)
Why was Trulight 5000/3000 Surgical Light recalled?
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical light system products listed below. Specific VidiaPort and Trulight product codes are also impacted as they are equipped with iLED 7 light-heads
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
a) UDI/DI 00887761968400, Serial Numbers: 107565745; b) UDI/DI 00887761968394, Serial Numbers: 107565746, 107592673, 107592675, 108034069
- Product
- Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical Lights)
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 5 units
- Distribution
- Worldwide distribution.
- Recall date
- July 17, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)