# China NMPA Product Recall - Nasal mucosal atomizing spray drug delivery device

Source: https://www.globalkeysolutions.net/records/china_product_recall/wolfe-tory-medical-inc/8fbd2e5f-4c89-4447-b0a4-25fd45ab16b4/
Source feed: China

> China NMPA product recall for Nasal mucosal atomizing spray drug delivery device by Wolfe Tory Medical, Inc. published December 05, 2016. Recall level: . The National Medical Products Administration (NMPA) issued a notice on December 5, 2016, concerning 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Wolfe Tory Medical, Inc. is recalling its nasal atomizing spray delivery devices.
- Company Name: Wolfe Tory Medical, Inc.
- Publication Date: 2016-12-05
- Product Name: Nasal mucosal atomizing spray drug delivery device
- Recall Reason: Terif Medical has received complaints that affected batches of its products produce a direct current instead of a nebulized spray. Nebulization failure may impair the efficacy of medications administered via this medical device. In certain emergency situations, such as reversing a life-threatening overdose of anesthetic drugs, hypoglycemia, or treating seizures without following instructions for needle-free administration, serious injury or death may result.
- Discovering Company: Telif Medical Devices Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Wolfe Tory Medical, Inc.
- Summary: The National Medical Products Administration (NMPA) issued a notice on December 5, 2016, concerning a global voluntary recall initiated by Wolfe Tory Medical, Inc., for its Nasal Nebulizer Spray Devices. The recall was prompted by reports indicating that affected product batches failed to produce a nebulized spray, instead emitting a direct current. This critical malfunction could significantly compromise the intended efficacy of medications delivered through the device, potentially leading to serious injury or death in emergency medical scenarios requiring precise drug administration, such as anesthesia, hypoglycemia reversal, or seizure treatment. While Wolfe Tory Medical Devices Trading (Shanghai) Co., Ltd. is the registered distributor, the manufacturer confirmed that the recalled devices (Registration Certificate No.: CFDA (Imported) 2013 No. 2665110) were not imported into or sold within mainland China. Consequently, no specific corrective actions were required from Chinese regulatory bodies concerning products in the Chinese market. However, provincial and municipal food and drug administration departments were instructed to maintain supervisory oversight over such products. The recall report, submitted by Teleflex MEDICAL, detailed the issue on November 3, 2016, emphasizing the potential for adverse health consequences due to the device's functional defect.

Company: https://www.globalkeysolutions.net/companies/wolfe-tory-medical-inc/0dac6055-ed34-4ae8-8419-5722710e3c23/