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Terminated

Terumo TenderFlow Pediatric Arterial Cannulae, 5.3 mm (16 Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813577.

FDA Recall Z-0884-2007 · Posted 2007-07-10

Recalling FirmTerumo Cardiovascular Systems Corp
Recall StatusTerminated
Product CodeDWF
Date Initiated2007-05-22
Date Terminated2009-07-07
Product Quantity58

Reason for Recall

The bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line).

Firm Action

Consignees were notified via phone beginning on 5/22/07 and by follow-up letters sent between 5/23/07 and 6/14/07.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K063618TENDERFLOW PERIATRIC ARTERIAL CANNULATerumo Cardiovascular Systems Corp. · 2007-03-13

Official Source

View FDA Recall →

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

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