FDA Device recall Z-2099-2014

Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating, Product Usage: The Aortic Cannula is indicated for…

FDA Device
Class II
terminated
Published 2014-07-30

On 2014-07-30 the FDA classified a Class II recall of Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating, Product Usage: The Aortic Cannula is indicated for… 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-2099-2014
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 Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating, Product Usage: The 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. 4948, Lot #: 0646471, 0652314, 0652909, 0656645, 0658692, 0662071, 0666665, 0669799, 0672089, 0675750, 0676585… Part No. 4948, Lot #: 0646471, 0652314, 0652909, 0656645, 0658692, 0662071, 0666665, 0669799, 0672089, 0675750, 0676585, 0678728, 0681792, 0684780, 0685667, 0688001, 0691202, 0693823, 0694711, 0696205, 0698300, 0708186, 0708766, 0710058, 0711914, 0714958, 0716134, 0717932, 0719278, 0721688, 694711R, 696201R; Part No. 4949, Lot #: 0646532, 0650731, 0651656, 0652458, 0655167, 0659823, 0661134, 0666626, 0667247, 0668568, 0669798, 0672411, 0675022, 0677305, 0677868, 0678727, 0681772, 0683304, 0683963, 0685668, 0687773, 0688994, 0694411, 0694706, 0695244, 0698301, 0703802, 0708185, 0708765, 0710054, 0711276, 0715262, 0716637, 0718634, 0720571, 695244R, 696204R; Part No. 4949X, Lot #: 0645381, 0653211, 0661604, 0667107, 0669928, 0684001, 0694715, 0712872, 694715R; Part No. 4950, Lot #: 0648462, 0650495, 0656442, 0657280, 0660743, 0674021, 0678721, 0681807, 0684779, 0687498, 0689723, 0693829, 0698851, 0708778, 0710056, 0711836, 0713283, 0719706, 693829R, 695465R; Part No. 4951, Lot #: 0645876

code_info

Part No. 4948, Lot #: 0646471, 0652314, 0652909, 0656645, 0658692, 0662071, 0666665, 0669799, 0672089, 0675750, 0676585…

Part No. 4948, Lot #: 0646471, 0652314, 0652909, 0656645, 0658692, 0662071, 0666665, 0669799, 0672089, 0675750, 0676585, 0678728, 0681792, 0684780, 0685667, 0688001, 0691202, 0693823, 0694711, 0696205, 0698300, 0708186, 0708766, 0710058, 0711914, 0714958, 0716134, 0717932, 0719278, 0721688, 694711R, 696201R; Part No. 4949, Lot #: 0646532, 0650731, 0651656, 0652458, 0655167, 0659823, 0661134, 0666626, 0667247, 0668568, 0669798, 0672411, 0675022, 0677305, 0677868, 0678727, 0681772, 0683304, 0683963, 0685668, 0687773, 0688994, 0694411, 0694706, 0695244, 0698301, 0703802, 0708185, 0708765, 0710054, 0711276, 0715262, 0716637, 0718634, 0720571, 695244R, 696204R; Part No. 4949X, Lot #: 0645381, 0653211, 0661604, 0667107, 0669928, 0684001, 0694715, 0712872, 694715R; Part No. 4950, Lot #: 0648462, 0650495, 0656442, 0657280, 0660743, 0674021, 0678721, 0681807, 0684779, 0687498, 0689723, 0693829, 0698851, 0708778, 0710056, 0711836, 0713283, 0719706, 693829R, 695465R; Part No. 4951, Lot #: 0645876

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-2099-2014%22

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