The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1055-2013·Announced 2013-04-10

LeMaitre Vascular Recalls Glow 'N Tell Tape Due to Sterility Compromise

LeMaitre Vascular is recalling Glow 'N Tell 20 cm Tape because manufacturing defects compromised the sterility of the devices.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (compromised sterility) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

LeMaitre Vascular, Inc. is recalling Glow 'N Tell 20 cm Tape, a medical device intended to be placed on the skin to assist during imaging procedures. The recall involves three specific lot codes: SGL1190 (exp 2017-02), SGL1196 (exp 2017-09), and SGL1197 (exp 2017-09). The total quantity of affected units is 13,560.

The recall was initiated because the devices were not sealed correctly during the manufacturing process, which compromised the sterility of the products. This defect poses a risk of infection or other adverse health consequences if the non-sterile tape is used on patients.

The affected products were distributed nationwide in the United States, as well as in Canada, the European Union, and Asia. Healthcare facilities and consumers who possess these specific lots should stop using the product immediately and contact LeMaitre Vascular, Inc. for instructions on return or replacement.

The recalled product

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 procedures.
Manufacturer
LeMaitre Vascular, Inc.
Category
Medical Device — Surgical/Imaging Accessories
Hazard
Affected units
13,560

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • SGL1190
  • exp 2017-02
  • SGL1196
  • exp 2017-09
  • SGL1197
  • exp. 2017-09

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by LeMaitre Vascular, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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