Boston Scientific brand Renegade 18 Fiber braided microcatheter, Catalog #: 18257, UPN: M001182570
FDA Recall Z-0177-2007 · Posted 2006-11-14
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Recalling FirmBoston Scientific Target
Recall StatusTerminated
Product CodeKRA
Date Initiated2006-10-13
Date Terminated2007-12-04
Product Quantity54 units
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)
Firm 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.
Root Cause
Other
Distribution Pattern
Class III Recall-Worldwide-USA and Australia
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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