Xhale Assurance, Inc.: 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

Recall number

Z-2133-2019

Recalling firm

Xhale Assurance, Inc.

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

Status

Terminated

Initiated

2019-05-08

Posted

not on file

Terminated

2022-04-25

Reason

These Instructions for Use has missing instructions related to the checking and changing of the application site procedure.

Root 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

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.

Lot, serial or model codes

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.

510(k) numbers

["K143216","K171423"]

PMA numbers

not on file

Product code

DQA

Firm FEI

1000113495

Firm city

Gainesville

Firm state

FL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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