Recall Z-0745-2022— Physio-Control, Inc.
Class III · Terminated
Class III FDA medical device recall by Physio-Control, Inc., initiated 2022-01-13, terminated 2023-05-19. FDA's recall record names no specific 510(k) clearance for this event. Product: HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak. Reason: Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs..
- Recalling firm
- Physio-Control, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2022-01-13
- Terminated
- 2023-05-19
- Firm location
- Redmond, WA, United States
Product description
HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak
Reason for recall
Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs.
Data sourced from openFDA. This site is unofficial and independent of the FDA.