Maquet Inc.: Medical Device Recall in 2012 - (Recall #: Z-2210-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 29, 2012

Date Posted: August 22, 2012

Recall Number: Z-2210-2012

Event ID: 62471

Reason for Recall:

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

Status: Terminated

Product Quantity: 20 devices US; 122 devices foreign

Code Information:

510k023251 US Catalog Number 161412 Batch Number 92048923 Foreign Catalog number 161412 Batch number 92048923 Catalog number 161412 Batch number 92051578

Distribution Pattern:

Worldwide Distribution - USA including MI, MN and Internationally

Voluntary or Mandated:

Voluntary: Firm initiated