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Terminated

Maquet HLM Tubing Pack; Bioline Coating

FDA Recall Z-2401-2010 · Posted 2010-09-12

Recalling FirmMaquet Inc.
Recall StatusTerminated
Product CodeDWE
Date Initiated2010-07-13
Date Terminated2011-08-10
Product Quantity5 units

Reason for Recall

The color of the tape on the arterial and the venous line were placed incorrectly, causing the connection of the arterial and the venous lines to be interchanged.

Firm Action

Recall notification letters were sent by Federal Express on July 13, 2010 to affected account and also an e-mail to the Maquet field representative who services the account.

Root Cause

Process control

Distribution Pattern

Distribution: Pennsylvania

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K053025JOSTRA HLM TUBING SETMaquet Cardiopulmonary, AG · 2005-11-10

Official Source

View FDA Recall →

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

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