Stryker PainPump1 5-Day Infusion Kit ; Product number 500-110-000.
FDA Recall Z-0663-06 · 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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.