8500M Handheld Pulse Oximeter
This recall has been terminated (originally issued September 29, 2016).
- Company
- Nonin Medical, Inc
- Recall Initiated
- September 29, 2016
- Terminated
- March 12, 2018
- Recall Number
- Z-1690-2017
- Quantity
- 15 (11 US; 4 OUS)
- Firm Location
- Plymouth, MN
- Official Source
- View on FDA website ↗
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.
Distribution
Distribution in US (MI, NC, OH, NC, VA), and CANADA
Lot / Code Info
502002091 502002088 502002087 502002083 502002085 502002086 502002081 502002082 502002080 502002079 502002077 502002078 502002089 502002090
Root Cause
Process control
Action Taken
Consignees 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.