Glow 'N Tell 20 cm Tape: 1100-00 recall: Sterility Concern
Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (20 strips). Intended to be placed on the skin to assist during imaging…
Why was Glow 'N Tell 20 cm Tape: 1100-00 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?
SGL1190, exp 2017-02; SGL1196, exp 2017-09; SGL1197, exp. 2017-09
- Product
- Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (20 strips). Intended to be placed on the skin to assist during imaging…
- Recalling firm
- LeMaitre Vascular, Inc.
- Quantity
- 13560
- 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)