CLASS II Device recall · Reported 10 Apr 2013 · FDA Enforcement Report
Glow 'N Tell Tape: 1100-00 (100 strips) recalled by LeMaitre Vascular
LeMaitre Vascular is recalling Glow 'N Tell Tape: 1100-00 (100 strips), distributed nationwide in the US. The recall was initiated on 18 Mar 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1055-2013
- FDA event ID
- 64704
- Recalling firm
- LeMaitre Vascular, Burlington, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Mar 2013
- FDA classified
- 4 Apr 2013
- Reported
- 10 Apr 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Imaging Equipment
Timeline
| 18 Mar 2013 | Recall initiated by company | |
| 4 Apr 2013 | Classified by FDA | +17 days |
| 10 Apr 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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 procedures.
Where it was distributed
Worldwide Distribution-USA (nationwide) and the countries of Canada, EU, and Asia.
Questions about this recall
Why was it recalled?
Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.
Which lots are affected?
SGL1190, exp 2017-02; SGL1196, exp 2017-09; SGL1197, exp. 2017-09
Where was it sold?
Worldwide Distribution-USA (nationwide) and the countries of Canada, EU, and Asia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 64704| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | LeMaitre Stent Guide: 1102-00 (100 strips) recalled by LeMaitre Vascular | LeMaitre Vascular | Sterility | Nationwide |
More recalls from LeMaitre Vascular
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|---|---|---|---|---|---|
| Device | CLASS II | Artegraft Vascular Graft recalled by LeMaitre Vascular | LeMaitre Vascular | Packaging Defects | Nationwide |
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