RecallDepth

Terumo TenderFlow Pediatric Arterial Cannulae, 2.7mm (8Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813570.

Company
Terumo Cardiovascular Systems Corp
Recall Initiated
May 22, 2007
Posted
July 10, 2007
Terminated
July 7, 2009
Recall Number
Z-0877-2007
Quantity
100
Firm Location
Ann Arbor, MI

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).

Distribution

Nationwide.

Lot / Code Info

Lot 2120265.

Root Cause

Other

Action Taken

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

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