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Terminated

Stryker Infravision Esophageal Kit, Model Numbers 220180548, 220180540, 220180560, manufactured by Stryker Endoscopy San Jose.

FDA Recall Z-0830-2011 · Posted 2010-12-28

Recalling FirmStryker Endoscopy
Recall StatusTerminated
Product CodeFAT
Date Initiated2009-08-20
Date Terminated2011-01-03
Product Quantity2985 units

Reason for Recall

The silicone sheath component of the product detaches from the catheter during removal of the e-kit from the body.

Firm Action

Stryker issued Urgent Product Recall letters dated August 20, 2009 to all its direct consignees, informing them of the affected products and providing instructions on the recall. Customers were requested to return the affected product to Styrker.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution: USA in the states of: Alabama, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia, and Wyoming, and the countries/region of Australia, Canada, Scandinavia, Italy, and Switzerland.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K983220STRYKER INFRAVISION ESOPHAGEAL KITStryker Endoscopy · 1999-06-04

Official Source

View FDA Recall →

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

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