Z-1424-2009

Medtronic, Transfer Spike, Blood Processing Accessory, REF BT945, Sequestration Kits

Name: Z-1424-2009 Medtronic, Transfer Spike, Blood Processing Accessory, REF BT945, Sequestration Kits
Creator: Medtronic Cardiovascular Revascularization & Surgical Therap
Published: 2009-02-25
License: https://open.fda.gov/license/

Medtronic Perfusion Systems / initiated 2009-02-25 / Terminated / root cause: design

FDA source

Medtronic Cardiovascular Revascularization & Surgical Therap began a recall of Medtronic, Transfer Spike, Blood Processing Accessory, REF BT945, Sequestration Kits on 2009-02-25. The reason FDA records is "Sterility may be compromised. Non-vented caps that connect to the 3-way stopcock attached to the transfer spike could prevent Ethylene Oxide from contacting the inside surfaces of the stopcock during sterilization...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1424-2009
Status: Terminated
Initiated: 2009-02-25
Posted: 2009-06-23
Terminated: 2011-05-07
Recalling firm: Medtronic Perfusion Systems
Product: Medtronic, Transfer Spike, Blood Processing Accessory, REF BT945, Sequestration Kits
Product code: DWE Tubing, Pump, Cardiopulmonary Bypass
Reason for recall: Sterility may be compromised. Non-vented caps that connect to the 3-way stopcock attached to the transfer spike could prevent Ethylene Oxide from contacting the inside surfaces of the stopcock during sterilization, leading to a potentially non-sterile product. Use of the product may cause serious health consequences from potential sepsis/infection and the associated remote risk of death.
Root cause tag: design
FDA root cause: Device Design
Action: Consignees were sent a Medtronic "Urgent Medical Device Recall Notice" letter dated March 5, 2009. The letter was addressed to Risk Manager. The letter described the product and problem and requested the consignee to complete, sign and return the certificate acknowledgement.
Quantity in commerce: 20 units
Distribution: Distribution to one medical facility in MN.
Product codes and lots: Lot 10279571, Use By 2012-01-31

Product code DWE

K800178Class IIExtracorp.'s Intersept Cus. Tubing Pk.Extracorporeal Medical Specialities, Inc. / cleared 1980-02-21

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)