COOK Stiffened Micropuncture Introducer Set, 5 FR. Product Reorder Number: MPIS-501-10.0-SC-U
FDA device recall Z-0434-03 · posted 2003-02-28 · Terminated
Recall details
- Recalling firm
- Cook, Inc.
- Reason for recall
- The tip of the stiffened cannula might break during use and remain in the patient.
- Action taken
- Recall letters were sent to each customer on November 26, 2002 advising them of the recall and to return stocks on hand.
- Root cause
- Other
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 393
- Distribution
- United States, Brazil, Canada, Dominican Republic and Israel.
- Date initiated
- 2002-11-25
- Date posted
- 2003-02-28
- Date terminated
- 2003-03-21
- Location
- Bloomington, IN
Monitor recalls programmatically
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