FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Corporation: 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.
- Recall number
- Z-0842-2012
- Recalling firm
- Terumo Cardiovascular 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.
- Status
- Terminated
- Initiated
- 2010-06-28
- Posted
- 2012-01-24
- Terminated
- 2012-02-29
- Reason
- Complaints were received of expired X-coated Capiox SX18 Hollow Fiber oxygenators.
- 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
- 16 units
- Distribution
- Nationwide Distribution including states of: WI, MO,and KY.
- Lot, serial or model codes
- Product code 3CXSX18RX, Lot # HF22
- 510(k) numbers
- ["K993772"]
- PMA numbers
- not on file
- Product code
- DTZ
- Firm FEI
- 3000204839
- Firm city
- Elkton
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28