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Terminated

Boston Scientific, Imager II Angiographic Catheter, (Outer Carton Label): UPN M001315081, 5 Fr, 100 cm, Catalog No. 31-508, Lot 48951, Description 5 Fr Flush TR, Sterile EO, Made in Ireland, Unit 7, 8 & 9, Annacotty Business Park, Annacotty, C. Limerick, Ireland ****Inner Pouch Label: Boston Scientific, Imager II Angiographic Catheter,UPN M001315080, 5 Fr, 100 cm, Catalog No. 31-508, Lot 48951, Description 5 Fr Flush TR, Sterile EO, Made in Ireland, Unit 7, 8 & 9, Annacotty Business Park, Annacotty, C. Limerick, Ireland

FDA Recall Z-0279-2008 · Posted 2007-12-06

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeDQO
Date Initiated2007-10-12
Date Terminated2007-12-19
Product Quantity14 boxes each containing 5 Units

Reason for Recall

Mislabeled: Units within the identified lot/batch were incorrectly labeled as 5F on the outer carton and pouch when the product was actually a 4F device.

Firm Action

Boston Scientific sent an Urgent Medical Device Recall -- Immediate Action Required letter to consignees on 10/12/07. The letter described the product and the mislabeling problem (labeled outer carton and pouch as 4F when they are actually 5F devices). The firm recommended segregating the affected product and to return it to Boston Scientific PLEASE NOTE: The firm's recall letter incorrectly addressed the mislabeling of this product recall. The mislabeling involves the labeled outer carton and pouch were labeled as 5F when the device enclosed in the pouch was a 4F device.

Root Cause

Packaging

Distribution Pattern

USA only including states of NJ, CA,TX,AZ

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050863IMAGER II ANGIOGRAPHIC CATHETERBoston Scientific Corp · 2005-09-02K011664IMAGER II ANGIOGRAPHIC CATHETERBoston Scientific/Medi-Tech · 2001-09-07

Official Source

View FDA Recall →

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

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