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Terminated

Model 8100 Series Medley Medication Safety System Pump Module

FDA Recall Z-0568-05 · Posted 2005-03-03

Recalling FirmAlaris Medical Systems Inc
Recall StatusTerminated
Product CodeFRN
Date Initiated2004-11-10
Date Terminated2005-09-02
Product Quantity55,200

Reason for Recall

The device modification is being implemented in response to information received from the field regarding a specific method of misloading the medication administration tubing set into the infusion system pump module. To date there have been complaints from three (3) different customer locations.

Firm Action

A device modification is being implemented in response to information received from the field regarding a specific method of misloading the medication administration tubing set into the infusion system pump module.

Root Cause

Other

Distribution Pattern

United States and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K012383GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT CAlaris Medical Systems, Inc. · 2001-10-02K950419THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETSImed Corp. · 1995-06-21

Official Source

View FDA Recall →

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

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