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Terminated

Stryker brand Insufflation Tube Set and High Flow Insufflation Tube Set, Model Numbers: 620-030-201, 620-030-301

FDA Recall Z-1177-06 · Posted 2006-06-27

Recalling FirmStryker Endoscopy
Recall StatusTerminated
Product CodeHET
Date Initiated2006-06-02
Date Terminated2006-11-20

Reason for Recall

Device for which sterility may be compromised as evidenced by a loss of package integrity.

Firm Action

On 6/2/06, 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

Packaging process control

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K943508INSUFFLATOR TUBING WITH FILTERStryker Endoscopy · 1994-11-17

Official Source

View FDA Recall →

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

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