Recall Z-0426-03 ยท DYB Introducer, Catheter
Cook, Inc.
COOK Stiffened Micropuncture Introducer Set, 4 FR. Product Reorder Number: MPIS-401-10.0-SC-NT
| Date | Feb 28, 2003 (initiated Nov 25, 2002) |
| Status | Terminated |
| Reason | The tip of the stiffened cannula might break during use and remain in the patient. |
| Root cause | Other |
| Action | Recall letters were sent to each customer on November 26, 2002 advising them of the recall and to return stocks on hand. |
| Quantity | 4,223 |
| Distribution | United States, Brazil, Canada, Dominican Republic and Israel. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.