Recall Z-1986-2023

Masimo Corporation · initiated April 21, 2023

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503

Codes / lots: UDI-DI: (01)00843997003230 Lot #: 13HBT, 15DAV, 17FAN, 17HAX, 17J12, 17MDF, 17N09, 18A28, 18AVB, 18CUV, 18FQZ, 18J33, 18K48,18KSS, 18MBC, 19ALF, 19CAY, 19D84, 19HMB, 19N1C, 20CRT, 20FMM, 20KWK, 21CRG, 21EMP, 21FFY,21FWV, 21G2K, 21GTL, 21HWG, 21KGD, 21MEF, 22AVS, 22BSC, 22DGZ, 22DUG, 22ESP, 22GDZ, 22J4J,22K64, 22NYC, 23AAE, E21DXT, K16HCA, K16JFC, K17BCR

Reason for recall

TC-I tip clip sensor may produce readings outside the accuracy specification.

FDA-determined cause: Nonconforming Material/Component

Action taken

On 5/17/2023, Masimo issued a Urgent: Medical Device Recall Notice via FedEx. Masimo asked consignees to take the following actions: 1. Contact Masimo Technical Services to request return of the affected part and lot number(s) for replacements and/ or if you have part numbers or lot numbers not included in this communication and have questions about those parts. 2. Masimo s Technical Services is available Monday through Friday 6:00am -5:00pm PST for live assistance or 24 hours a day to leave a message and someone will contact you. Local contact information can be found at http://service.masimo.com. 3. Complete Attachment 1, then email it to CustomerNotice@masimo.com, or Fax it to 1-949-297-7575 by MM DD, 2023. 4. Any adverse reaction or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program online, by regular mail or by fax.

Details

Recall number
Z-1986-2023
Initiated
April 21, 2023
Posted by FDA
June 21, 2023
Product code
DQA – Oximeter
Quantity
123,745 units
Distribution
US: AK , AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY OUS: Argentina, Australia, Austria, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Gibraltar…
Recalling firm
Masimo Corporation, Irvine, CA

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1983-2023 Class IIMasimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053TC-I tip clip sensor may produce readings outside the accuracy specification. 04/21/2023Open, Classified
Z-1984-2023 Class IIMasimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794TC-I tip clip sensor may produce readings outside the accuracy specification. 04/21/2023Open, Classified
Z-1985-2023 Class IIMasimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895TC-I tip clip sensor may produce readings outside the accuracy specification. 04/21/2023Open, Classified