Recall Z-0745-2022 ยท MKJ Automated External Defibrillators (Non-Wearable)
Physio-Control, Inc.
HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak
| Date | Jan 13, 2022 |
| Status | Terminated |
| Reason | Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs. |
| Root cause | Process control |
| Action | On 01/13/2022, Stryker telephoned the customer and informed them of the correction. The telephone call was followed up with a correction notice, mailed to the customer on 01/17/22, that informed the customer to contact Customer Service at 1 800 787 9537, option 2, 8:00 A.M. to 7:00 P.M. (Eastern Time), Monday - Friday or by email at medtechsup@stryker.com if they had questions or concerns. |
| Quantity | 1 |
| Distribution | U.S.: AK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.