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Terminated

Maquet Coronary Perfusion Cannulae with Balloon Tip, with either self-inflating balloon tip or cone distal tips, straight or right angle, available with proximal end fittings for either 1/4 inch connector or male luer fitting, Model numbers 210800, 210801, 210802, 210803, 210804, 210805, 210806, 210807, 210810, 210811, 210812, 210813, 210814, 210815, 210816, 210817, 215800, 215802, 215803, 215804, 215805, 215806, 215807, 215810, 215811, 215812, 215813, 215814, 215815, 215816, and 215817.

FDA Recall Z-1869-2009 · Posted 2009-08-31

Recalling FirmMaquet Cardiovascular
Recall StatusTerminated
Product CodeDWF
Date Initiated2009-05-19
Date Terminated2010-12-21
Product Quantity2,226 devices

Reason for Recall

Undeclared allergen: Products are missing the warning label declaring that the products contain natural rubber latex.

Firm Action

Maquet Cardiovascular issued a notification letter to consignees on May 19, 2009.

Root Cause

Process control

Distribution Pattern

Nationwide distribution.

Official Source

View FDA Recall →

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

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