Recall Z-0842-2012 ยท DTZ Oxygenator, Cardiopulmonary Bypass
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
| Date | Jan 24, 2012 (initiated Jun 28, 2010) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993772 | X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR Terumo Medical Corp., Jun 5, 2000 |