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RD SET recallZ-1983-2023 · Masimo Corporation · initiated Apr 21, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Masimo Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Nonconforming Material/Component

What the company is doing

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 [email protected], 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.

Recall details

Recall number
Z-1983-2023
Status
Open, Classified
Initiated by the company
Apr 21, 2023
Posted by the FDA
Jun 21, 2023
Recalling firm
Masimo Corporation
Quantity
138,926 units
Product code
DQA
FDA submissions
K180046
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, Guernsey, Hong Kong, Hungary, Iceland, India, Israel, Italy, Japan, Jersey, Jordan, Kenya, Lebanon, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Palestinian Territory, Poland, Portugal, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.

Product description

Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

UDI-DI: (01)00843997009904 Lot #: E16JZJ, E16N2C, 17A3A, 17AKM, 17AKN, 17CPV, 17DBE, 17E87, 17E88, 17FAQ, 17GEV, 17J13, 17KBP,17KWZ, 17MDH, 18AEG, 18DCE, 18E04, 18GNZ, 18HKS, 18J35, 18JPH, 18JWM, 18K49, 18KST, 18M03,19BFG, 19CBA, 19D87, 19DZS, 19EAN, 19F47, 19GCW, 19HDJ, 19HTV, 19K3N, 19KAP, 19KPZ, 19M2U,19MKM, 19NRL, 20ABM, 20C76, 20C94, 20DAL, 20FUR, 20G2S, 20HFU, 20KMY, 20KUE, 20MNW, 20NGC,21ASU, 21CBY, 21CTU, 21E08, 21E09, 21EMQ, 21EMR, 21EYS, 21EYT, 21FUF, 21FUG, 21G2S, 21GAG,21JDD, 21JXV, 21K09, 21MAT, 21NEW, 22ADL, 22APR, 22BJM, 22C29, 22D18, 22DRN, 22FHY, 22FYS,22G1W, 22HHW, 22HYW, 22JHE, 22JZX, 22K65, 22M1A, 22M6V, 22MPZ, 22N9G, 22NHZ, 23A2J, 23AAF,23AEX, 23AJG, 23BEN, 23C5X, E20H1H, E21DYW, E21G2N, E21HCQ, E21HMJ, E21HMK, E23CVQ, R17BXM

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

2 devices cleared under K180046 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 92371).

Sources and updates

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