Product in clear plastic pouch labeled: Boston Scientific MEDI-TECH *** VASCULAR DILATOR *** Order No./REF: 48-151 M0014
FDA device recall Z-0842-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corp
- Reason for recall
- Product labeled at Vascular Dilator Set 5 Fr contains 5 dilators ranging from 6 Fr to 14 Fr.
- Action taken
- Letter dated 4/2/04 flagged as an addendum to a letter dated 3/18/04, with instructions to return product.
- Root cause
- Other
- Status
- Terminated
- Product code
- DRE
- Quantity affected
- 43 units
- Distribution
- Hospitals in CA, CT, FL, GA, IL, MI, NM, OH, WA, WI.
- Date initiated
- 2004-03-18
- Date posted
- 2004-07-20
- Date terminated
- 2005-10-25
- Location
- Glens Falls, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.