Product in clear plastic pouch labeled: Boston Scientific MEDI-TECH *** VASCULAR DILATOR *** Order No./REF: 48-151 M001481510, 5 Fr. Firm on the label: Boston Scientific Corporation, 480 Pleasant Street, Watertown, MA 02472.
This recall has been terminated (originally issued July 20, 2004).
- Company
- Boston Scientific Corp
- Recall Initiated
- March 18, 2004
- Posted
- July 20, 2004
- Terminated
- October 25, 2005
- Recall Number
- Z-0842-04
- Quantity
- 43 units
- Firm Location
- Tech Park Glens Falls, NY
- Official Source
- View on FDA website ↗
Reason for Recall
Product labeled at Vascular Dilator Set 5 Fr contains 5 dilators ranging from 6 Fr to 14 Fr.
Distribution
Hospitals in CA, CT, FL, GA, IL, MI, NM, OH, WA, WI.
Lot / Code Info
929123, Exp. 12/2006
Root Cause
Other
Action Taken
Letter dated 4/2/04 flagged as an addendum to a letter dated 3/18/04, with instructions to return product.
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