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U.S. Department of Health and Human Services

Class 1 Device Recall LIFEPAK(R) defibrillation electrodes

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  Class 1 Device Recall LIFEPAK(R) defibrillation electrodes see related information
Date Initiated by Firm October 27, 2017
Date Posted December 12, 2017
Recall Status1 Terminated 3 on June 12, 2019
Recall Number Z-0187-2018
Recall Event ID 78303
510(K)Number K022732  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product LIFEPAK(R) Electrode Starter Kits, Catalog # 11101-000017, MIN #3202784-009

The defibrillation electrodes are used only with LIFEPAK EXPRESS(R) AED, LIFEPAK CR(R) Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED s with a pink connector.
Code Information 45932237, 46042286, 45979590, 46050960, 45979954, 46052545, 46007867, 46061770, 46023185, 46063054, 46023823, 46078012, 
Recalling Firm/
Manufacturer		 Physio-Control, Inc.
11811 Willows Rd NE
Redmond WA 98052-2003
For Additional Information Contact
866-231-1220
Manufacturer Reason
for Recall		 The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type BF Patient connection and High Voltage Warning symbols.
FDA Determined
Cause 2		 Process control
Action The firm Physio Control, initiated their field action on 10/27/2017 by issuing a press release. The firm followed this with a recall notice dated 10/23/2017, to the direct consignees on 11/03/2017. The letter described the product, explained the problem and provided the following instructions: Quarantine the affected lots;contact Physio-Control at 1-866-231-1220, 6:00 A.M. to 4:00 P.M. (Pacific), Monday  Friday to arrange for replacement of your unused electrodes and "Upon receipt of this notification, post a copy of the enclosed Correct Electrode and Packaging Labeling with each of your AEDs, which shows the correct placement of the electrodes." Physio_Control will provide replacement products for all unused affected Electrodes. Should you have any questions about this Product Recall, please contact us at 1-866-231-1220, 6:00 A.M. to 4:00 P.M. (Pacific), Monday  Friday.
Quantity in Commerce 14,219 units in total
Distribution Worldwide distribution: US (nationwide) including Puerto Rico and Guam and countries of: Canada, Austria, Belgium, Czech Republic; Denmark, Finland, France, French Polynesia, Germany, Hungary, Ireland, Italy, Latvia, Netherlands, Australia, China, Hong Kong, Japan, Argentina, Mexico, Norway, Panama, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom, and New Zealand.
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 = MEDTRONIC PHYSIO-CONTROL CORP.
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