FDA Enforcement
Class II
Terminated
10 ga ARS Decompression Needle, Part Number ZZ-0298
Recall: Z-2520-2021
·
Reported September 29, 2021
Enforcement
- Recall Number
- Z-2520-2021
- Event ID
- 88603
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- North American Rescue LLC.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 29, 2021
- Initiation Date
- August 27, 2021
- Classification Date
- September 23, 2021
- Termination Date
- January 19, 2024
- Address
- 35 Tedwall Ct, Greer, SC, 29650-4791, United States
Description
10 ga ARS Decompression Needle, Part Number ZZ-0298
Reason
The device includes the incorrect Instructions for Use.
Code Info
Part Number, ZZ-0298; Lots: o W668NI, W693WF, W694ZH, W695DD, W696FN, W697IJ
Distribution
Distribution throughout US and Puerto Rico OUS consignees in Australia, Czech Republic, Denmark, France, Germany, Ireland, Italy, Poland, and Switzerland
Quantity
51,424 units