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Terminated

SmartBlock Pain Management System, Part numbers P49524, P49534, P49624, and P49634.

FDA Recall Z-1022-2010 · Posted 2010-03-08

Recalling FirmHsmg, Inc. D/b/a Smartinfuser Usa
Recall StatusTerminated
Product CodeMEB
Date Initiated2009-01-08
Date Terminated2011-04-25
Product Quantity444 units

Reason for Recall

Product leaks associated with a new pump reservoir, and incident related to regulator fast priming feature.

Firm Action

SmartInfuser USA sent letters to consignees on 1/8/2009 and 1/22/2009.

Root Cause

Process control

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072053SMARTBLOCK PAIN PUMPMedical Flow Systems, Ltd. · 2007-11-06

Official Source

View FDA Recall →

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

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