Class 2 Device Recall Nasal Alar SpO2 Sensor

• Date Initiated by Firm: May 08, 2019
• Create Date: July 30, 2019
• Recall Status: Terminated on April 25, 2022
• Recall Number: Z-2133-2019
• Recall Event ID: 82817
• 510(K)Number: K143216 K171423
• Product Classification: Oximeter - Product Code DQA
• Product: 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
• 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.
• Recalling Firm/ Manufacturer: Xhale Assurance, Inc.; 3630 Sw 47th Ave Ste 100; Gainesville FL 32608-7555
• For Additional Information Contact: 352-371-8488
• Manufacturer Reason for Recall: These Instructions for Use has missing instructions related to the checking and changing of the application site procedure.
• FDA Determined Cause: Device Design
• Action: Xhale Assurance, Inc. notified consignees on about 05/08/2019, via "URGENT - Medical Device Correction" letter. Customers were instructed to insert the IFU Addendum into each case of sensors for ready reference, review all information provided in the updated IFU Addendum with all members of your staff whom need to be aware of the updated instructions, and complete and return the provided Customer Reply Form. Distributors were instructed to insert the IFU Addendum into each case of sensors for ready reference, provide a copy of the Field Safety Notice and IFU Addendum to any customer to whom affected devices have been distributed to, and complete and return the provided Customer Reply Form.
• Quantity in Commerce: 701,272 devices total
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DQA and Original Applicant = Xhale, Inc; 510(K)s with Product Code = DQA and Original Applicant = Xhale, Inc.