Recall Z-0279-2008 ยท DQO Catheter, Intravascular, Diagnostic
Boston Scientific Corporation
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,
| Date | Dec 6, 2007 (initiated Oct 12, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Packaging |
| 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. |
| Quantity | 14 boxes each containing 5 Units |
| Distribution | USA only including states of NJ, CA,TX,AZ |
| FDA record | Open on fda.gov |