# China NMPA Product Recall - Handheld carbon dioxide/pulse oximeter

Source: https://www.globalkeysolutions.net/records/china_product_recall/tyco-healthcare-group-lp-nellcor-puritan-bennett-division/eafe4a53-0f05-4e97-8752-69d0d7350d0b/
Source feed: China

> China NMPA product recall for Handheld carbon dioxide/pulse oximeter by Tyco Healthcare Group LP Nellcor Puritan Bennett Division published May 16, 2011. Recall level: . Tyco Healthcare Group LP Nellcor Puritan Bennett Division initiated a voluntary medical device recal

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Tyco Healthcare Group LP Nellcor Puritan Bennett Division is recalling handheld carbon dioxide/pulse oximeters.
- Company Name: Tyco Healthcare Group LP Nellcor Puritan Bennett Division
- Publication Date: 2011-05-16
- Product Name: Handheld carbon dioxide/pulse oximeter
- Recall Reason: Recently, a manufacturing issue was discovered in certain batches of Oridion Medical's Microstream® FilterLine® sampling tubing infant/newborn kits (Oridion part number 006324), which were marketed with the FilterLine® sampling tubing and the Nellcor (Covidien) N85 monitor.
- Discovering Company: Singapore Tyco Medical Devices Co., Ltd. Beijing Representative Office
- Manufacturing Company: Tyco Healthcare Group LP Nellcor Puritan Bennett Division
- Summary: Tyco Healthcare Group LP Nellcor Puritan Bennett Division initiated a voluntary medical device recall on May 16, 2011, for specific handheld carbon dioxide/pulse oximeters. The recall, managed under the oversight of the National Medical Products Administration (NMPA), was prompted by a manufacturing issue discovered in certain batches of Oridion Medical's Microstream® FilterLine® sampling tubing kits (part number 006324). These kits were intended for use with the OFFIC (Covidien) N85 monitor, providing continuous, non-invasive monitoring of respiratory and blood oxygen parameters, particularly for infants and newborns. The identified issue relates to production problems within the sampling tubing kits, with the N85 monitor itself remaining unaffected. Although there is a potential for tubing breakage, the risk of patient harm has been assessed as very low. Under the NMPA's regulatory framework, Tyco Healthcare Group is required to identify and destroy the affected sampling tubing kits received by customers within their N85 monitor packages. Concurrently, the NMPA directed provincial Food and Drug Administrations to enhance their oversight of such products. The company confirmed the field action was in its initial stages, with further updates on recalled products anticipated. While the recall impacts regions including Canada, Mexico, Europe, USA, and Singapore, no affected products were imported or sold within China.

Company: https://www.globalkeysolutions.net/companies/tyco-healthcare-group-lp-nellcor-puritan-bennett-division/92dac02b-bbf5-4091-89b0-ebef19b8e99c/