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Terminated

Nonin Model 2500 PalmSAT handheld pluse Oximeter , Nonin Medical, Inc., Plymouth, MN USA

FDA Recall Z-0843-2008 · Posted 2008-04-11

Recalling FirmNonin Medical, Inc
Recall StatusTerminated
Product CodeDQA
Date Initiated2007-10-11
Date Terminated2011-12-18
Product Quantity240

Reason for Recall

Incorrect Label: The label on the back of the device may show Model 2500A rather than Model 2500.

Firm Action

An Urgen Field Action letters was sent (10/11/07) to Nonin distributors who received the potentially mislabeled product. The letters provided labeling differences and included instructions for notifying their customers, with a response form to be returned to Nonin. For additional information please contact Kim Aves at 763-577-3196.

Root Cause

Error in labeling

Distribution Pattern

Worldwide Distribution ---- USA including states of ME, SC, SD, CA, MO, NY, MI, FL, IL, PA, NC, CT, and TX, and countries of Canada, Greece, Russia, Italy, Sweden, Australia, & Japan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050056MODEL 2500A PALMSAT PULSE OXIMETERNonin Medical, Inc. · 2005-06-21K002690MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500Nonin Medical, Inc. · 2000-10-11

Official Source

View FDA Recall →

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

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