Z-1019-03
Wallstent Enteral Endoprothesis with Unistep Plus Delivery, 20 mm X 90 mm Catalog Number: 6557
Boston Scientific Corporation / initiated 2003-06-26 / Terminated / root cause: labeling and UDI
Boston Scientific Corporation began a recall of Wallstent Enteral Endoprothesis with Unistep Plus Delivery, 20 mm X 90 mm Catalog Number: 6557 on . The reason FDA records is "Mislabeled: Product is labeled as a 20 mm X 90 mm, but is actually a 22 mm X 60 mm". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-1019-03
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Boston Scientific Corporation
- Product
- Wallstent Enteral Endoprothesis with Unistep Plus Delivery, 20 mm X 90 mm Catalog Number: 6557
- Reason for recall
- Mislabeled: Product is labeled as a 20 mm X 90 mm, but is actually a 22 mm X 60 mm
- Root cause tag
- labeling and UDI
- FDA root cause
- Other
- Action
- Boston Scientific notified domestic and internationnal accounts by letter on 6/26/03. Users are advised to check inventory and return product. A Reply Verification form was required to returned by fax to determine accountability.
- Quantity in commerce
- 23 units
- Distribution
- CO, FL, IA, IL, NY, VT,TX Foreign: Singapore, Korea
- Product codes and lots
- Lot Number: 5404484
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