Z-2133-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 7, 2019
- Initiation Date
- May 8, 2019
- Termination Date
- April 25, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 701,272 devices total
Product Description
Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only Product Usage: The Assurance¿ Nasal Alar SpO2 Sensor is indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients, (at least 4 years and older and weighing > 15kg). The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision
Reason for Recall
These Instructions for Use has missing instructions related to the checking and changing of the application site procedure.
Distribution Pattern
US Nationwide distribution to AZ, CA, FL, KS, LA, MA , MO, MS, NC, NY, OH, PA, TX, WI. International distribution to Canada, Germany, Malaysia, United Kingdom.
Code Information
Reference Codes (Lot Numbers): 0303 (101619, 101624, 101628, 101632, 101637, 101642, 101646, 101647, 101651, 101701, 201651, 101707, 101715, XH101711, XH101720, XH101715, XH101726, XH101729, XH101733, XH101737, XH101820, XH101842), 301-11214 (TR101711, TR101715, TR101720, TR101726, TR101729, TR101744, TR101733, TR101737, TR101748, TR101742, TR101746, TR101750, TR101803, TR101811, TR101817, TR101820, TR101824, TR101829, TR101833, TR101838, TR101842, TR101847, TR101852), 0201-A01(PF101736, PF101806, PF101814, PF101817, PF101819, PF101822, PF101828, PF101833, PF101838). Instructions for Use for revisions 10412_7 and prior (i.e. 10412_6, 10412_5, etc) as well as 10358_6 and prior. Shelf life is 3 years for sensors manufactured prior to Oct 2018. 5 years for sensor manufactured on or after Oct 2018.