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U.S. Department of Health and Human Services

Class 2 Device Recall FASTPAK

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  Class 2 Device Recall FASTPAK see related information
Date Initiated by Firm February 27, 2008
Date Posted August 24, 2008
Recall Status1 Terminated 3 on March 07, 2011
Recall Number Z-1567-2008
Recall Event ID 46921
510(K)Number K761043  K890079  K951593  K973486  
Product Classification Battery, External Automatic Defibrillator - Product Code MKJ
Product 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.
Code Information All batteries with lot code 0624.
Recalling Firm/
Manufacturer		 Physio Control, Inc.
11811 Willows Rd Ne
Redmond WA 98052-2003
For Additional Information Contact Todd Bandy
425-867-4000
Manufacturer Reason
for Recall		 Batteries mislabeled - batteries labeled as 2.4 amp/hour batteries, however are 1.0 amp/hour batteries.
FDA Determined
Cause 2		 Labeling mix-ups
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.
Quantity in Commerce 811 batteries
Distribution Batteries were distributed nationwide and to Canada, Netherlands, Asia Pacific and Latin America.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MKJ and Original Applicant = PHYSIO-CONTROL CORP.
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