Recall Z-0301-2024
Physio-Control, Inc. · initiated September 29, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020
Codes / lots: UDI: 00883873871713/ Serial number: 44174756, 46013280, 46966395, 48149013
Reason for recall
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
FDA-determined cause: Under Investigation by firm
Action taken
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 RSRecall@Stryker.com. 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: rsdevicetracking@stryker.com b. Website: https://www.strykeremergencycare.com/service-support-overview/device-registration/
Details
- Recall number
- Z-0301-2024
- Initiated
- September 29, 2023
- Posted by FDA
- November 14, 2023
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
- Quantity
- 4 units
- Distribution
- US Nationwide distribution in the states of AZ, CA, NC, NJ, NY.
- Recalling firm
- Physio-Control, Inc., Redmond, WA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0296-2024 Class II | LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | 09/29/2023Open, Classified |
| Z-0297-2024 Class II | LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | 09/29/2023Open, Classified |
| Z-0298-2024 Class II | LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | 09/29/2023Open, Classified |
| Z-0299-2024 Class II | LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | 09/29/2023Open, Classified |
| Z-0300-2024 Class II | LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | 09/29/2023Open, Classified |
| Z-0302-2024 Class II | LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | 09/29/2023Open, Classified |
| Z-0303-2024 Class II | LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | 09/29/2023Open, Classified |
| Z-0304-2024 Class II | LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | 09/29/2023Open, Classified |
| Z-0305-2024 Class II | LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026Their is a potential for battery pins to become loose within the defibrillator resulting in power issues. | 09/29/2023Open, Classified |