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Terminated

Stryker Endoscopy, Infravision Esophageal Kit, Model Numbers: 220180548, 220180540, 220180560

FDA Recall Z-1002-2011 · Posted 2011-02-01

Recalling FirmStryker Endoscopy
Recall StatusTerminated
Product CodeFAT
Date Initiated2010-05-11
Date Terminated2011-02-01
Product Quantity4125

Reason for Recall

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

Firm Action

On 5/11/10, Stryker Endoscopy initiated the recall notification letters explaining the reason for the recall and requesting the product be returned.

Root Cause

Device Design

Distribution Pattern

Nationwide and 3 foreign consignees (Canada, Singapore 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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