Terumo Sarns cardiovascular disposable products, Weighted Flexible Sucker, sterile, Terumo Cardiovascular Systems Corp.,
FDA device recall Z-2046-2009 · posted 2009-08-04 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Reason for recall
- A loose strand of stainless steel left on the device during manufacturing may result in an unretrieved metal fragment remaining in the patient.
- Action taken
- Consignees were notified via Urgent - Medical Device Removal letters dated 2/5/08 to cease use of the product. Terumo CVS will contact customers to arrange replacement for the affected product upon receipt of the attached response form. Questions are to be directed to Terumo CVS Customer Service at 1-800-521-2818.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DTS
- Quantity affected
- 7079
- Distribution
- Worldwide Distribution --- including USA and countries of Belgium, Brazil, Dominican Republic, Germany, Jordan and Latin America.
- Date initiated
- 2008-02-05
- Date posted
- 2009-08-04
- Date terminated
- 2009-11-01
- Location
- Ann Arbor, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS (K982891) | California Medical Laboratories, Inc. | 1998-09-30 |