| Class 3 Device Recall Boston Scientific Imager II Angiographic Catheter | |
Date Initiated by Firm | October 12, 2007 |
Date Posted | December 06, 2007 |
Recall Status1 |
Terminated 3 on December 19, 2007 |
Recall Number | Z-0279-2008 |
Recall Event ID |
45432 |
510(K)Number | K011664 K050863 |
Product Classification |
Intravascular Diagnostic Catheter - Product Code DQO
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Product | 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 |
Code Information |
Lot No: 48951 |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation One Boston Scientific Place Natick MA 01760
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For Additional Information Contact | 763-494-1700 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 in Commerce | 14 boxes each containing 5 Units |
Distribution | USA only including states of NJ, CA,TX,AZ |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = DQO 510(K)s with Product Code = DQO
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