Recall Z-1311-2008 ยท OEZ Cardiovascular Procedure Kit
Terumo Cardiovascular Systems Corp
Cardiovascular Procedure Kit, P/N 64789-01, Wisconsin Cardiovascular Services Pump and Table Pack, Terumo Cardiovascular, Ashland, MA. (the Pump & table pack contains a weighted flexible sucker, Catalog No. 804113)
| Date | Mar 28, 2008 (initiated Jan 29, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 110 |
| Distribution | Nationwide-USA including states of Missouri, Tennessee and Wisconsin-Custom Kits for 3 hospitals. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982891 | CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS California Medical Laboratories, Inc., Sep 30, 1998 |