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U.S. Department of Health and Human Services

Class 3 Device Recall Boston Scientific Imager II Angiographic Catheter

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 Class 3 Device Recall Boston Scientific Imager II Angiographic Cathetersee related information
Date Initiated by FirmOctober 12, 2007
Date PostedDecember 06, 2007
Recall Status1 Terminated 3 on December 19, 2007
Recall NumberZ-0279-2008
Recall Event ID 45432
510(K)NumberK011664 K050863 
Product Classification Intravascular Diagnostic Catheter - Product Code DQO
ProductBoston 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
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
ActionBoston 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 Commerce14 boxes each containing 5 Units
DistributionUSA only including states of NJ, CA,TX,AZ
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = DQO
510(K)s with Product Code = DQO
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