FDA Device recall Z-2102-2014

Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr with 1/2" flare or connector Product Usage: Venous Re…

FDA Device
Class II
terminated
Published 2014-07-30

On 2014-07-30 the FDA classified a Class II recall of Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr with 1/2" flare or connector Product Usage: Venous Re… 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-2102-2014
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

Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr with 1/2" flare or connector Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava

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. 813580, Lot #: AM004245, AM006060, AM016524; Part No. 813579, Lot #: AM001313, AM007311, AM007721, AM009067, A… Part No. 813580, Lot #: AM004245, AM006060, AM016524; Part No. 813579, Lot #: AM001313, AM007311, AM007721, AM009067, AM016176, AM016523, AM018165; Part No. 813582, Lot #: AM001293, AM017320; Part No. 813581, Lot #: AM002694, AM003543, AM006059, AM017959; Part No. 813584, Lot #: AM001311, AM002688, AM002730, AM006055, AM016188, AM016639; Part No. 813583, Lot #: AM002729, AM006054, AM016187, AM016638, AM018071; Part No. 813586, Lot #: AM001303, AM005726, AM006061, AM008349; Part No. 813585, Lot #: AM002473, AM002728, AM006056, AM010935, AM017208; Part No. 813588, Lot #: AM002690, AM002699, AM003781, AM004252, AM006058, AM008238, AM016477; Part No. 813587, Lot #: AM001314, AM002687, AM003782, AM006057, AM008237, AM016189, AM016476, AM018297; Part No. 813590, Lot #: AM016920 & Part No. 813589, Lot #: AM002720, AM004287.

code_info

Part No. 813580, Lot #: AM004245, AM006060, AM016524; Part No. 813579, Lot #: AM001313, AM007311, AM007721, AM009067, A…

Part No. 813580, Lot #: AM004245, AM006060, AM016524; Part No. 813579, Lot #: AM001313, AM007311, AM007721, AM009067, AM016176, AM016523, AM018165; Part No. 813582, Lot #: AM001293, AM017320; Part No. 813581, Lot #: AM002694, AM003543, AM006059, AM017959; Part No. 813584, Lot #: AM001311, AM002688, AM002730, AM006055, AM016188, AM016639; Part No. 813583, Lot #: AM002729, AM006054, AM016187, AM016638, AM018071; Part No. 813586, Lot #: AM001303, AM005726, AM006061, AM008349; Part No. 813585, Lot #: AM002473, AM002728, AM006056, AM010935, AM017208; Part No. 813588, Lot #: AM002690, AM002699, AM003781, AM004252, AM006058, AM008238, AM016477; Part No. 813587, Lot #: AM001314, AM002687, AM003782, AM006057, AM008237, AM016189, AM016476, AM018297; Part No. 813590, Lot #: AM016920 & Part No. 813589, Lot #: AM002720, AM004287.

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-2102-2014%22

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