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.
Reported: April 10, 2013 Initiated: March 18, 2013 #Z-1054-2013
Product Description
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.
Reason for Recall
Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.
Details
- Recalling Firm
- LeMaitre Vascular, Inc.
- Units Affected
- 6970
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Canada, EU, and Asia.
- Location
- Burlington, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by LeMaitre Vascular, Inc.. Units affected: 6970.
Why was this product recalled? ▼
Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 10, 2013. Severity: Moderate. Recall number: Z-1054-2013.
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