Z-0884-2007

Terumo TenderFlow Pediatric Arterial Cannulae, 5.3 mm (16 Fr) OD, with 1/4 inch vented connector, 9 inch...

Name: Z-0884-2007 Terumo TenderFlow Pediatric Arterial Cannulae, 5.3 mm (16 Fr) OD, with 1/4 inch vented connector, 9 inch...
Creator: Terumo Cardiovascular Systems Corp
Published: 2007-05-22
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2007-05-22 / Terminated

FDA source

Terumo Cardiovascular Systems Corp began a recall of 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 on 2007-05-22. The reason FDA records is "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)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0884-2007
Status: Terminated
Initiated: 2007-05-22
Posted: 2007-07-10
Terminated: 2009-07-07
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: 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.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
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).
FDA root cause: Other
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.
Quantity in commerce: 58
Distribution: Nationwide.
Product codes and lots: Lot 2120272.

Product code DWF

K063618Class IITenderflow Periatric Arterial CannulaTerumo Cardiovascular Systems Corp. / cleared 2007-03-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)