LeMaitre Stent Guide: 1102-00 recall: Sterility Concern
LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin to assist during imaging…
Why was LeMaitre Stent Guide: 1102-00 recalled?
Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
LSG1130, exp. 2017-04; LSG1132, exp. 2017-11
- Product
- LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin to assist during imaging…
- Recalling firm
- LeMaitre Vascular, Inc.
- Quantity
- 6970
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Canada, EU, and Asia.
- Recall date
- April 10, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)