Recall Z-0842-2012
Terumo Cardiovascular Corporation · initiated June 28, 2010
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.
Codes / lots: Product code 3CXSX18RX, Lot # HF22
Reason for recall
Complaints were received of expired X-coated Capiox SX18 Hollow Fiber oxygenators.
FDA-determined cause: Employee error
Action taken
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.
Details
- Recall number
- Z-0842-2012
- Initiated
- June 28, 2010
- Posted by FDA
- January 24, 2012
- Terminated
- February 29, 2012
- Product code
- DTZ – Oxygenator, Cardiopulmonary Bypass
- Quantity
- 16 units
- Distribution
- Nationwide Distribution including states of: WI, MO,and KY.
- Recalling firm
- Terumo Cardiovascular Corporation, Elkton, MD