Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall BD

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall BD see related information
Date Initiated by Firm October 09, 2014
Date Posted December 12, 2014
Recall Status1 Terminated 3 on April 24, 2015
Recall Number Z-0572-2015
Recall Event ID 69604
Product Classification Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
Product BD Insyte Autoguard Catheter
An active safety engineered peripheral IV catheter with a retracting needle to reduce accidental needle stick injuries. The safety feature (needle retraction) of this device is activated when the clinician depresses the button located on the superior surface of the grip. This product is used to provide access to the intravascular system for administration of fluids, medication, blood and blood products and for the withdrawal of the blood samples.
Code Information Distributed in USA   REF#381433 20 G x 1.00 in. BD Insyte Autoguard 1.1 x 25 mm 65ml/min Lot numbers 4139786, Exp May-17; 4161662, Jun-17; 4164960, Jun-17; 4167812, Jun-17; 4174713, Jun-17; 4182668, Jun-17; 4182668, Jul-17  REF 381434 20 G x 1.16 in. BD Insyte Autoguard 1.1 x 30 mm 60 ml/min  Lot numbers 4105724, Apr-17; 4107722, Apr-17; 4113707, Apr-17; 4113713, Apr-17  Distributed outside of USA  REF# 381833 20G x 1.00 in. BD Insyte Autoguard 1.1 x 25 mm 65 ml/min Lot4143917, May -17  REF 3811834 20 G x 1.16 in. BD Insyte AUtoguard 1.1 x 30 mm 60ml/min  Lot numbers 4119700, May-17; 4119730, May-17; 4129576, May-17; 4147742, May-17; 4107722, Apr-17      
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Ms. Yogindra Dellow
201-847-6800
Manufacturer Reason
for Recall		 BD Insyte Autoguard may have potential damage along the body of the catheter.
FDA Determined
Cause 2		 Device Design
Action BD sent an 'Urgent:Voluntary Product Recall Letters/Notice of Return ' dated October 9, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory, quarantine the affected product, and return all affected product with the completed Notice of Return form following the instruction on the enclosed packing instruction. Upon receipt of the returned product, BD will issue a credit. Customers who do not have of the affected product were also asked to complete the Notice of Return form indicating (0) quantity and return form back to BD by fax to 1-201-847-6990. If the product was further distributed customers were instructed to identify their customers and notify them at once of the product recall. Customers with questions were instructed to call 201-847-4267.
Quantity in Commerce US- 296,800 devices; OUS - 3,250,150 devices
Distribution Worldwide Distribution - USA (naitonwide) and Internationally to South Africa, Spain, Italy, Canada, Japan, Panama, Costa Rica, Mexico, Peru, and Timor Leste.
Total Product Life Cycle TPLC 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.
-
-