RegWardenFDA facility compliance records
Recall

Class II — Maquet Inc.

Recalling firmMAQUET (Suzhou) Co., Ltd
Registered facilityMAQUET (SUZHOU) CO., LTD (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonCertain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened" cannula tip.
ProductMaquet 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
Quantity20 devices US; 122 devices foreign
DistributionWorldwide Distribution - USA including MI, MN and Internationally
Initiated2012-05-29
Classified2012-08-15
Terminated2014-04-03
Recall numberZ-2210-2012
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Maquet Inc. (Z-2210-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/62471/

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