Class 2 Device Recall Maquet Getinge Group Pediatric Arterial Cannula

• Date Initiated by Firm: May 29, 2012
• Date Posted: August 15, 2012
• Recall Status: Terminated on April 03, 2014
• Recall Number: Z-2210-2012
• Recall Event ID: 62471
• 510(K)Number: K023251
• Product Classification: Cannula, arterial, cardiopulmonary bypass (cpb), embolism protection - Product Code NCP
• Product: Maquet Getinge Group Pediatric Arterial Cannula ; Maquet Cardiopulmonary AG Kehler Strabe 31; 76437 Rastatt Germany Phone +49 7222 932-0; Fax: +49 7222 932-1888; info.cp@maquet.com; www.maquet.com; ; Used to introduce blood and sterile solution to the circulation system during extracorporeal circulation procedures
• Code Information: 510k023251 US Catalog Number 161412 Batch Number 92048923 Foreign Catalog number 161412 Batch number 92048923 Catalog number 161412 Batch number 92051578
• Recalling Firm/ Manufacturer: Maquet Inc.; 45 Barbour Pond Drive; Wayne NJ 07470
• For Additional Information Contact: Ms. Karen LeFevere; 973-709-7652
• Manufacturer Reason for Recall: Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened" cannula tip.
• FDA Determined Cause: Device Design
• Action: 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.
• Quantity in Commerce: 20 devices US; 122 devices foreign
• Distribution: Worldwide Distribution - USA including MI, MN and Internationally

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NCP and Original Applicant = POLYSTAN A/S