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Terminated

Renegade Hi-Flo Microcatheter Kits, Catalog/Order # 18-299, UPN M001182990

FDA Recall Z-0122-2007 · Posted 2006-11-01

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeKRA
Date Initiated2005-08-10
Date Terminated2012-05-16
Product Quantity5 units

Reason for Recall

Outer box of the product may have an incorrect expiration date listed as 2007-06, while the correct expiration date is 2007-04

Firm Action

Recall notification packages including a Reply Verification Tracking Form were sent to Boston Scientific representatives via Fed Ex on 8/10/2005. Boston Scientific representatives delivered the packages to the consignees. The Consignees were instructed to return affected product to Boston Scientific to be relabeled.

Root Cause

Other

Distribution Pattern

TX, KY

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K000177RENEGADE HI-FLO MICROCATHETERBoston Scientific Corp · 2000-04-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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