| Class 2 Device Recall Masimo LNCS TCI SpO2, Ref: 1895 | |
Date Initiated by Firm | April 21, 2023 |
Date Posted | June 21, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1985-2023 |
Recall Event ID |
92371 |
510(K)Number | K051212 |
Product Classification |
Oximeter - Product Code DQA
|
Product | Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895 |
Code Information |
UDI-DI: (01)00843997000048
Lot #: 13NBR, 13NBS, 14B96, 14CWW, 14GFV, 14JFW, 14KYQ, 14N03, 15C01, 15EBB, 15HNT, 17DCG, 17DCH,17DCJ, 17DYJ, 17DYK, 17E83, 17E84, 17FAL, 17FAM, 17GER, 17GNT, 17HAV, 17HLA, 17HLB, 17HZD, 17J08,17J09, 17JRE, 17KBQ, 17KBR, 17MDD, 17MDE, 17MPD, 17N06, 17N07, 17NFD, 18A26, 18A27, 18B99, 18BAA, 18CCT, 18CWV, 18CYG, 18DCB, 18EEC, 18ENJ, 18FAG, 18G1V, 18GND, 18GUC, 18H3N, 18HVP, 18J32, 18JPJ, 18JVL, 18K47, 18K52, 18M01, 18M02, 18NAE, 19AAA, 19AHL, 19B2G, 19BFC, 19CAB, 19CAC, 19CUX, 19D83, 19DGK, 19DVR, 19EAJ, 19EAK, 19EVJ, 19F43, 19FUY, 19GCV, 19GSX, 19GZX, 19JEE, 19JVK, 19K42, 19K4V, 19KAM, 19KQB, 19M09, 19M11, 19M2V, 19NDD, 20A4H, 20ABN, 20BBT, 20BKJ, 20BWP, 20C74, 20CRU, 20DAK, 20EQM, 20F49, 20FPD, 20G31, 20G8F, 20HFV, 20HRK, 20J5J, 20JLT, 20K2C,
20KGW, 20KQS, 20MJX, 20MST, 20NGB, 20NGD, 20NUT, 21AGX, 21AXQ, 21BJG, 21BVK, 21CMG, 21DFN, 21EFA, 21EMS, 21EXD, 21EYU, 21F6J, 21FFZ, 21FUH, 21GFE, 21H2M, 21HCT, 21HUC, 21HWH, 21JDQ, 21K4B, 21KGZ, 21MUT, 21MWW, 21NEB, 21NLV, 21NZA, 22ADM, 22BVR, 22CJE, 22CJN, 22CSZ, 22CYA, 22DBL, 22DMJ, 22DSG, 22E72, 22E91, 22EGL, 22EQD, 22EZD, 22F75, 22FHH, 22G2E, 22G68, 22GTT, 22HKY, 22HSC, 22JGD, 22JGE, 22K4N, 22K4P, 22KJM, 22KMJ, 22M7N, 22MCX, 22MZS, 22N6Y, 22N9L, 22NGX, 22NRV, 23AEY, 23AJH, 23BEK, 23BRZ, 23BSS, 23CER, E19DLJ, E20CLS, E20FNS, E20FNT, E20H1G, E20HGW, E21DYY, E21G7M, K16AER, K16DDY, K16GFA, K16JDS, K16KFD, K16KFE, K16NFF,K16NFG,K17AEV, K17AEW, K17B2G, K17BCP, K17BUY, K17CFJ, K17CFK, K17CFM, K17CFN |
Recalling Firm/ Manufacturer |
Masimo Corporation 52 Discovery Irvine CA 92618-3105
|
For Additional Information Contact | Masimo Technical Services 949-297-7575 |
Manufacturer Reason for Recall | TC-I tip clip sensor may produce readings outside the accuracy specification. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | 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. |
Quantity in Commerce | 443,799 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, 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. |
Total Product Life Cycle | TPLC Device Report |
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = DQA
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