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Terminated

StrykeFlow II Disposable Suction/Irrigator; AHTO Tube Set; Model Numbers: 250-070-500, 250-070-520, 250-070-540, 250-070-600, 250-070-620; Product is distributed by Stryker Endoscopy, 5900 Optical Court San Jose, CA 95138

FDA Recall Z-0279-06 · Posted 2005-12-14

Recalling FirmStryker Endoscopy
Recall StatusTerminated
Product CodeGCX
Date Initiated2005-11-18
Date Terminated2006-11-02
Product Quantity48405 boxes, 6 units per box

Reason for Recall

Devices for which sterility may be compromised as evidenced by a crack in the package.

Firm Action

On 11/18/05, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned.

Root Cause

Other

Distribution Pattern

The product was distributed nationally to 1321 consignees and internationally to 18 consignees.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042454STRYKER CASSETTE PUMPStryker Endoscopy · 2004-12-09

Official Source

View FDA Recall →

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

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