# China NMPA Product Recall - Semi-automatic external defibrillator

Source: https://www.globalkeysolutions.net/records/china_product_recall/physio-control-inc/720af2d7-94eb-43f7-adc8-378c5c7d5fe0/
Source feed: China

> China NMPA product recall for Semi-automatic external defibrillator by Physio-Control, Inc. published December 01, 2017. Recall level: Level 2. Physio-Control, Inc., in collaboration with its agent Beijing Jietong Kangnuo Pharmaceutical Technol

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Physio-Control, Inc. Active Recall of Semi-Automatic External Defibrillators
- Company Name: Physio-Control, Inc.
- Publication Date: 2017-12-01
- Product Name: Semi-automatic external defibrillator
- Recall Level: Level 2
- Recall Reason: Physio-Control, Inc. has discovered that illustrations on the packaging of certain batches of its low-energy infant defibrillator pads do not conform to Physio-Control specifications, and that the electrode placement for infants is incorrectly indicated. The affected low-energy infant defibrillator electrodes are not defective in performance or function; the issue is limited to illustrations on the electrode pads within the packaging showing incorrect electrode placement for infants. No related customer complaints have been reported.
- Discovering Company: Beijing Jietong Kangnuo Pharmaceutical Technology Co., Ltd.
- Manufacturing Company: Physio-Control, Inc.
- Summary: Physio-Control, Inc., in collaboration with its agent Beijing Jietong Kangnuo Pharmaceutical Technology Co., Ltd., initiated a voluntary recall of specific batches of its semi-automatic external defibrillators. This action, reported to the National Medical Products Administration (NMPA) on November 22, 2017, addresses a critical labeling error. The primary issue concerns an incorrect illustration on the packaging of certain low-energy infant defibrillator electrode pads, depicting an improper electrode placement for infants. While the functionality and performance of the defibrillator electrodes remain unaffected, this graphic inaccuracy could lead to misuse. The recall is classified as Class III by NMPA and a global Level Two, indicating a remote probability of adverse health consequences. Under NMPA guidance, required actions include the immediate cessation of use of affected low-energy infant defibrillator electrodes (Model: 11101-000016, Batch numbers: 713609, 717912). Additionally, customers are instructed to retrieve and ensure the destruction of all unused affected electrodes to prevent potential user error stemming from the mislabeled instructions. This recall impacts 30 units manufactured or imported into China, with 5 already sold in the region.

Company: https://www.globalkeysolutions.net/companies/physio-control-inc/c025f05e-3b2b-4081-a12e-0e310448bbe6/