FDA Device recall Z-2094-2014

Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with or without side holes and/or luer Product Usage: The Sarns Aort…

FDA Device
Class II
terminated
Published 2014-07-30

On 2014-07-30 the FDA classified a Class II recall of Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with or without side holes and/or luer Product Usage: The Sarns Aort… by Terumo Cardiovascular Systems, citing during an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2094-2014
Classification	Class II
Status	terminated
Initiated	2014-05-23
Published	2014-07-30
Last updated	2026-09-13 11:53 UTC
Company	Terumo Cardiovascular Systems
Distribution	US

Product

Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with or without side holes and/or luer Product Usage: The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

Reason

During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications

Identifiers

code_info	Part No. 165269, Lot #: 0649648, 0652316, 0653402, 0659824, 0678725, 0682564; Part No. 9482, Lot #: 0653227, 0656440, 0… Part No. 165269, Lot #: 0649648, 0652316, 0653402, 0659824, 0678725, 0682564; Part No. 9482, Lot #: 0653227, 0656440, 0673777; Part No. 4344, Lot #: 0645166, 0653856, 0673024; Part No. 9485, Lot #: 654068; Part No. 9486, Lot #: 649867; Part No. 4400, Lot #: 0650491, 0659436, 0669133, 0674461; Part No. 165267, Lot #: 0654562, 0672209, 0676284, 0678213; Part No. 165266, Lot #: 0658973, 0661133, 0667798, 0675018, 0678084; Part No. 9483, Lot #: 0649709, 0653442, 0655043; Part No. 4460, Lot #: 0667803, 0675761, 0677655; Part No. 165765, Lot #: 677007; Part No. 165265, Lot #: 0652644, 0659820, 0674746, 0683956; Part No. 165264, Lot #: 0646481, 0650489, 0653235, 0668894, 0676282, 0681876, 0683955 & Part No. 9484, Lot #: 0649158, 0655040, 0660676.

code_info

Part No. 165269, Lot #: 0649648, 0652316, 0653402, 0659824, 0678725, 0682564; Part No. 9482, Lot #: 0653227, 0656440, 0…

Part No. 165269, Lot #: 0649648, 0652316, 0653402, 0659824, 0678725, 0682564; Part No. 9482, Lot #: 0653227, 0656440, 0673777; Part No. 4344, Lot #: 0645166, 0653856, 0673024; Part No. 9485, Lot #: 654068; Part No. 9486, Lot #: 649867; Part No. 4400, Lot #: 0650491, 0659436, 0669133, 0674461; Part No. 165267, Lot #: 0654562, 0672209, 0676284, 0678213; Part No. 165266, Lot #: 0658973, 0661133, 0667798, 0675018, 0678084; Part No. 9483, Lot #: 0649709, 0653442, 0655043; Part No. 4460, Lot #: 0667803, 0675761, 0677655; Part No. 165765, Lot #: 677007; Part No. 165265, Lot #: 0652644, 0659820, 0674746, 0683956; Part No. 165264, Lot #: 0646481, 0650489, 0653235, 0668894, 0676282, 0681876, 0683955 & Part No. 9484, Lot #: 0649158, 0655040, 0660676.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2094-2014%22

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