Z-2133-2019Class II

Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only

Name: Z-2133-2019 Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only
Creator: Xhale Assurance, Inc.
Published: 2019-05-08
License: https://open.fda.gov/license/

Invivo Corporation / initiated 2019-05-08 / Terminated / root cause: design

FDA source

Xhale Assurance, Inc. began a recall of 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... on 2019-05-08. FDA classified it as Class II and gives the reason as "These Instructions for Use has missing instructions related to the checking and changing of the application site procedure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2133-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-08
Posted: 2019-07-30
Terminated: 2022-04-25
Recalling firm: Invivo Corporation
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
Product code: DQA Oximeter
Reason for recall: These Instructions for Use has missing instructions related to the checking and changing of the application site procedure.
Root cause tag: design
FDA 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 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2133-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2133-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30

Product code DQA

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)