Terumo Cardiovascular Systems CAPIOX (r) SX18 Hollow Fiber Oxygenator LOT: HF22 . 2010-04 The X-coated Capiox SX18 Hollo
FDA device recall Z-0842-2012 · posted 2012-01-24 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Corporation
- Reason for recall
- Complaints were received of expired X-coated Capiox SX18 Hollow Fiber oxygenators.
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- DTZ
- Quantity affected
- 16 units
- Distribution
- Nationwide Distribution including states of: WI, MO,and KY.
- Date initiated
- 2010-06-28
- Date posted
- 2012-01-24
- Date terminated
- 2012-02-29
- Location
- Elkton, MD
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR (K993772) | Terumo Medical Corp. | 2000-06-05 |