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Terminated

LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006 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.

FDA Recall Z-0186-2018 · Posted 2017-12-12

Recalling FirmPhysio-Control, Inc.
Recall StatusTerminated
Product CodeMKJ
Date Initiated2017-10-27
Date Terminated2019-06-12
Product Quantity14,219 units in total

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K022732INFANT/CHILD REDUCED ENERGY ELECTRODESMedtronic Physio-Control Corp. · 2002-12-13

Official Source

View FDA Recall →

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

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