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Terminated

Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 4 mL/hr, 2 mL bolus, 60 minute bolus refill, sterile, REF 0535-426-000.

FDA Recall Z-1856-2009 · Posted 2009-09-04

Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product CodeMEB
Date Initiated2009-05-14
Date Terminated2010-01-20
Product Quantity28,755 of all pumps

Reason for Recall

Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.

Firm Action

Stryker sent all consignees a Medical Device Recall Notification letter dated 5/14/09 and instructed to locate and destroy the recalled products and to complete and return the business reply card.

Root Cause

Process control

Distribution Pattern

Nationwide and Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060258AUTOFUSERAce Medical Us, LLC · 2006-05-30K041585AUTOFUSER AMBULATORY INFUSION PUMPAlgos, LC · 2004-08-26

Official Source

View FDA Recall →

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

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