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Terminated

8500M Handheld Pulse Oximeter

FDA Recall Z-1690-2017 · Posted None

Recalling FirmNonin Medical, Inc
Recall StatusTerminated
Product CodeDQA
Date Initiated2016-09-29
Date Terminated2018-03-12
Product Quantity15 (11 US; 4 OUS)

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.

Firm Action

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 [email protected] or via direct telephone at 763 577 3196.

Root Cause

Process control

Distribution Pattern

Distribution in US (MI, NC, OH, NC, VA), and CANADA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K893221MODEL 8500 HAND HELD PULSE OXIMETERNonin Medical, Inc. · 1990-02-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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