Z-0299-2024Class II
LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602
Physio Control, Inc. / initiated 2023-09-29 / Open, Classified
Physio-Control, Inc. began a recall of LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602 on . FDA classified it as Class II and gives the reason as "Their is a potential for battery pins to become loose within the defibrillator resulting in power issues". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-0299-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Physio Control, Inc.
- Product
- LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602
- Product code
- MKJ Automated External Defibrillators (Non-Wearable)
- Reason for recall
- Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
- FDA root cause
- Under Investigation by 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/
- Quantity in commerce
- 5 units
- Distribution
- US Nationwide distribution in the states of AZ, CA, NC, NJ, NY.
- Product codes and lots
- UDI: 00883873911648/ Serial number: 40644322 40644323 40644331 42221204 42934131
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0296-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0297-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0298-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0299-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0300-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0301-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0302-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0303-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0304-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0305-2024 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.