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Terminated

TriVex 100SV Resector Kit, 4.5 Part Number: 7205876

FDA Recall Z-1226-06 · Posted 2006-07-13

Recalling FirmSmith & Nephew, Inc. Endoscopy Division
Recall StatusTerminated
Product CodeGEI
Date Initiated2006-06-19
Date Terminated2008-01-10
Product Quantity8631 units/Expanded1071 units

Reason for Recall

The sterility seal of the package trays may have incomplete seals compromising the sterility of the device

Firm Action

Smith & Nephew initiated the recall by Certified Letter on June 19, 2006 requesting return of the recalled products. Smith & Nephew expanded the recall to include additional lots. The firm issued the recall expansion letter dated 8/25/06.

Root Cause

Other

Distribution Pattern

Nationwide and Austria, China, Germany, Finland, Italy, South Africa, South Korea, Switzerland, UK.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K990723DYONICS VARICOSE VEIN ABLATION BLADESmith & Nephew, Inc. · 1999-10-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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