Cardiovascular Procedure Kit, P/N 70295-02, St. Louis University Hospital Pump & Table Pack, Terumo Cardiovascular, Ashl
FDA device recall Z-1312-2008 · posted 2008-03-28 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Reason for recall
- Loose Flash at tip of Weighted Flexible Sucker: A loose strand of stainless steel left on the device during manufacturing by an outside supplier may result in an unretrieved metal fragment remaining in the patient.
- Action taken
- Consignees were notified via recall letter, Urgent Medical Device Removal, dated 1/29/08 via fax or email to cease using the weighted sucker in the packs and to use an alternative sucker until replacement product arrives from Terumo.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- OEZ
- Quantity affected
- 20
- Distribution
- Nationwide-USA including states of Missouri, Tennessee and Wisconsin-Custom Kits for 3 hospitals.
- Date initiated
- 2008-01-29
- Date posted
- 2008-03-28
- Date terminated
- 2009-07-07
- 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 |