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U.S. Department of Health and Human Services

Class 2 Device Recall Nonin

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 Class 2 Device Recall Noninsee related information
Date Initiated by FirmSeptember 29, 2016
Create DateMarch 28, 2017
Recall Status1 Terminated 3 on March 12, 2018
Recall NumberZ-1690-2017
Recall Event ID 75424
510(K)NumberK893221 
Product Classification Oximeter - Product Code DQA
Product8500M Handheld Pulse Oximeter
Code Information 502002091  502002088  502002087  502002083  502002085  502002086 502002081  502002082  502002080  502002079  502002077  502002078  502002089 502002090
Recalling Firm/
Manufacturer		 Nonin Medical, Inc
13700 1st Ave N
Plymouth MN 55441-4595
For Additional Information ContactKim E. Aves
763-577-3196
Manufacturer Reason
for Recall		Nonin manufactures and sells two 8500 handheld pulse oximeters (Model 8500 with no memory feature and the 8500M which has a memory feature). Some of the devices distributed may not have the correct pulse oximetry board with the integrated memory feature.
FDA Determined
Cause 2		Process control
ActionConsignees were called and sent on 9-29-2016 a Nonin Urgent Medical Device Recal" letter dated 29 September, 2016. The letter described the problem and the product involved in the recall. Additionally, it described the Potential Risk and Required Action. Requested consignees to return the affected units and to forward the contact information if the unit is no longer in their inventory. For questions contact Kim.Aves@nonin.com or via direct telephone at 763 577 3196.
Quantity in Commerce15 (11 US; 4 OUS)
DistributionDistribution in US (MI, NC, OH, NC, VA), and CANADA
Total Product Life CycleTPLC Device Report
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DQA
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