Z-0177-2007
Boston Scientific brand Renegade 18 Fiber braided microcatheter, Catalog #: 18257, UPN: M001182570
Boston Scientific Corporation / initiated 2006-10-13 / Terminated / root cause: labeling and UDI
Boston Scientific Target began a recall of Boston Scientific brand Renegade 18 Fiber braided microcatheter, Catalog #: 18257, UPN: M001182570 on . The reason FDA records is "Incorrect expiration date: The product's exterior box date may be labeled with a longer than actual expiration date (the pouch label is correct)". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-0177-2007
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Boston Scientific Corporation
- Product
- Boston Scientific brand Renegade 18 Fiber braided microcatheter, Catalog #: 18257, UPN: M001182570
- Product code
- KRA Catheter, Continuous Flush
- Reason for recall
- Incorrect expiration date: The product's exterior box date may be labeled with a longer than actual expiration date (the pouch label is correct)
- Root cause tag
- labeling and UDI
- FDA root cause
- Other
- Action
- On 10/6/06, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned. Product will be destroyed upon return.
- Quantity in commerce
- 54 units
- Distribution
- Class III Recall-Worldwide-USA and Australia
- Product codes and lots
- Lot #: 7513978
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