Bard Orbiter ST Artrial Mapping Steerable Catheter Item Numbers 320001 7FAM00001 7FAM00010 7FAM00019 7FAM0008B 7FAM0017B
FDA device recall Z-0602-03 · posted 2003-02-28 · Terminated
Recall details
- Recalling firm
- C. R.Bard, Inc./Electrophysiology Division
- Reason for recall
- Sterile barrier maybe perforated compromising sterility of the device
- Action taken
- Bard Electrophysiology notified direct accounts by letter on 1.08.03 via Fed''X. Accounts are requested to return product.
- Root cause
- Packaging process control
- Status
- Terminated
- Quantity affected
- 6784 units
- Distribution
- Nationwide
- Date initiated
- 2003-01-08
- Date posted
- 2003-02-28
- Date terminated
- 2012-05-03
- Location
- Billerica, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.