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Open, Classified

LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061

FDA Recall Z-0297-2024 · Posted 2023-11-14

Recalling FirmPhysio-Control, Inc.
Recall StatusOpen, Classified
Product CodeMKJ
Date Initiated2023-09-29
Product Quantity8 yrs.

Reason for Recall

Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.

Firm Action

On October 6, 2023, Stryker issued a "Urgent Medical Device Correction" Notification to affected consignees. Stryker ask consignees to take the following actions: 1. Please check your internal inventory to locate the affected product listed on the attached business reply form. 2. To confirm receipt of this Medical Device Notice and understanding of the provided information, please email the enclosed Business Reply Form (BRF) by October 31, 2023, to [email protected]. 3. Once the BRF is received, a Stryker Representative will contact you to arrange for corrective action on the device. There are no additional actions that users can and should take. 5. In the interim, Stryker recommends that you continue to use your LP15 v4 device. 6. Maintain awareness of this communication internally until all required actions have been completed within your facility. 7. Inform Stryker if any of the subject devices have been distributed to other organizations by contacting Stryker at: a. Device Tracking: [email protected] b. Website: https://www.strykeremergencycare.com/service-support-overview/device-registration/

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the states of AZ, CA, NC, NJ, NY.

Official Source

View FDA Recall →

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

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