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Terminated

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 [email protected] www.maquet.com Used to introduce blood and sterile solution to the circulation system during extracorporeal circulation procedures

FDA Recall Z-2210-2012 · Posted 2012-08-15

Recalling FirmMaquet Inc.
Recall StatusTerminated
Product CodeNCP
Date Initiated2012-05-29
Date Terminated2014-04-03
Product Quantity20 devices US; 122 devices foreign

Reason for Recall

Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened" cannula tip.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - USA including MI, MN and Internationally

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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