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Terminated

Stryker PainPump1 Base Kit; Product number 500-100-000.

FDA Recall Z-0662-06 · Posted 2006-03-21

Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product CodeMEA
Date Initiated2006-02-03
Date Terminated2007-06-04

Reason for Recall

The catheter tubing included in the kit may break during removal.

Firm Action

Each consignee was notified of the recall via recall letter dated 2/7/06, which requested that they destroy the affected lots on site. International accounts were notified via email.

Root Cause

Other

Distribution Pattern

Nationwide, Australia and Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042405PAINPUMP1; PAINPUMP2Stryker Corp. · 2004-10-14

Official Source

View FDA Recall →

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

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