Exact FDA event identifier

Event 64704

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: March 18, 2013
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: LeMaitre Vascular, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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 procedures.

Z-1054-2013

Recall number: Z-1054-2013
Initiated: March 18, 2013
Classification: Class II
Status: Terminated
Recalling firm: LeMaitre Vascular, Inc.
Quantity: 6970

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.

Code information

LSG1130, exp. 2017-04; LSG1132, exp. 2017-11

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Canada, EU, and Asia.

device · product 2 of 2

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.

Z-1055-2013

Recall number: Z-1055-2013
Initiated: March 18, 2013
Classification: Class II
Status: Terminated
Recalling firm: LeMaitre Vascular, Inc.
Quantity: 13560

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.

Code information

SGL1190, exp 2017-02; SGL1196, exp 2017-09; SGL1197, exp. 2017-09

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Canada, EU, and Asia.