Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

FASTPAK batteries labeled Manufactured for Medtronic Physio-Control 11811 Willows Rd, Redmond, WA USA. Batteries are Nickel-Cadmium (NiCd) battery packs used to provide DC power to LIFEPAK 5, 10, 11, or 12 defibrillator/monitors. The FASTPAK battery has a capacity of 1 amp/hour (1.0AH). The FASTPAK battery can be charged in a Battery Support System, Battery Support System 2, Mobile Battery Service Station, or the LIFEPAK 10, 11 or 12 defibrillator/monitor when the device is powered by an external power adapter. The FASTPAK battery does not have a pushbutton fuel gauge like the LIFEPAK NiCd. The fuel gauge provides a visual indication of battery capacity. Battery part number 9-10424-18. Sold with LIFEPAK defibrillators and also sold separately.

FDA Recall Z-1567-2008 · Posted 2008-08-24

Recalling FirmPhysio Control, Inc.
Recall StatusTerminated
Product CodeMKJ
Date Initiated2008-02-27
Date Terminated2011-03-07
Product Quantity811 batteries

Reason for Recall

Batteries mislabeled - batteries labeled as 2.4 amp/hour batteries, however are 1.0 amp/hour batteries.

Firm Action

On February 27, 2008, the firm sent a "URGENT MEDICAL DEVICE - ACCESSORY RECALL" letter via certified return receipt to their consignees. The letter states the batteries are fully functional 1.0 amp/hour batteries mislabeled as 2.4 amp/hour batteries and that the batteries will provide half the monitoring time and half the number of defibrillation shock as of a 2.4 amp/hour LIFEPAK NiCd battery. Enclosed with the letter is a confirmation sheet for the consignee to indicate the number of recalled batteries they have and fax back to the firm. The firm will send out replacement batteries and the consignee is to then send back the mislabeled batteries. If there are any questions, contact the technical support group at 1-800-442-1142 - option 5 or visit www.physio-control-notices.come/fastpak.

Root Cause

Labeling mix-ups

Distribution Pattern

Batteries were distributed nationwide and to Canada, Netherlands, Asia Pacific and Latin America.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K973486LIFE PAK 12Physio-Control Corp. · 1998-01-09K951593LIFEPAK 11Physio-Control Corp. · 1995-12-29K890079LIFEPAK 10 DEFIBRILLATOR/MONITORPhysio-Control Corp. · 1989-02-23

Official Source

View FDA Recall →

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

↑