Recall Z-0745-2022
Physio-Control, Inc. · initiated January 13, 2022
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak
Codes / lots: GTIN/UDI: 05060167120695, Serial Number: 20D00009694
Reason for recall
Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0745-2022
- Initiated
- January 13, 2022
- Terminated
- May 19, 2023
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
- Quantity
- 1
- Distribution
- U.S.: AK
- Recalling firm
- Physio-Control, Inc., Redmond, WA