U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened" cannula tip.
조치
Maquet issued Urgent Device 2, Recall letters/Urgent Product Recall Forms dated May 29, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their current stock and identify any affected product and remove from their inventory. Customers were instructed to contact the customer service department at 800-777-4222 (option #2, followed by option #2). Customers were also instructed to completed the enclsoed Recall Form to acknowledge receipt of the notification and to document the current status of the devices shipped to their facility. For questions regarding this recall call 973-709-7660.
510k023251 US Catalog Number 161412 Batch Number 92048923 Foreign Catalog number 161412 Batch number 92048923 Catalog number 161412 Batch number 92051578