Z-0842-2012

Terumo Cardiovascular Systems CAPIOX (r) SX18 Hollow Fiber Oxygenator LOT: HF22 . 2010-04 The X-coated Capiox...

Name: Z-0842-2012 Terumo Cardiovascular Systems CAPIOX (r) SX18 Hollow Fiber Oxygenator LOT: HF22 . 2010-04 The X-coated Capiox...
Creator: Terumo Cardiovascular Corporation
Published: 2010-06-28
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2010-06-28 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Corporation began a recall of Terumo Cardiovascular Systems CAPIOX (r) SX18 Hollow Fiber Oxygenator LOT: HF22 . 2010-04 The X-coated Capiox SX18 Hollow Fiber Oxygenators with Detachable... on 2010-06-28. The reason FDA records is "Complaints were received of expired X-coated Capiox SX18 Hollow Fiber oxygenators". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0842-2012
Status: Terminated
Initiated: 2010-06-28
Posted: 2012-01-24
Terminated: 2012-02-29
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: Terumo Cardiovascular Systems CAPIOX (r) SX18 Hollow Fiber Oxygenator LOT: HF22 . 2010-04 The X-coated Capiox SX18 Hollow Fiber Oxygenators with Detachable Hardshell Reservoir are used to exchange gases between extracorporeal blood and a gaseous environment during cardiopulmonary bypass procedures. The integral heat exchanger is used to warm or cool the blood or perfusion fluid and the detachable hardshell reservoir is used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line. The reservoir contains a venous section that is comprised of a filter and defoamer to facilitate air bubble removal.
Product code: DTZ Oxygenator, Cardiopulmonary Bypass
Reason for recall: Complaints were received of expired X-coated Capiox SX18 Hollow Fiber oxygenators.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: All customers were contacted by telephone between 6/28/10 and 7/2/10. The manufacturer mailed "Urgent Medical Device Removal " letters to customers on 01/16/12 with receipt confirmation requested. Customers were informed that expired product had been shipped. Use of expired product was not recommended and product return was requested for refund. Contact Terumo CVS Customer Service 1-800-521-2818 for questions.
Quantity in commerce: 16 units
Distribution: Nationwide Distribution including states of: WI, MO,and KY.
Product codes and lots: Product code 3CXSX18RX, Lot # HF22

Product code DTZ

K993772Class IIX-Coated Capiox Sx18 and Sx25 Hollow Fiber Oxygenator with/ without Detachable Hardshell ReservoirTerumo Medical Corp. / cleared 2000-06-05

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)