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 Broselow/Hinkle Pediatric Emergency System

  • 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 Broselow/Hinkle Pediatric Emergency System see related information
Date Initiated by Firm June 30, 2009
Date Posted September 08, 2009
Recall Status1 Terminated 3 on August 27, 2012
Recall Number Z-1912-2009
Recall Event ID 52694
Product Classification Needle, aspiration and injection, disposable - Product Code GAA
Product Broselow/Hinkle Pediatric Emergency System;
Contents: 1 15 Ga Adjustable Length Sternal/Iliac aspiration Needle; 1 Extension Set, Sterile. Equipment Color Zone: Green, Single Patient use,
INTRAOSSEUS Module, Product # 7700GIO, Vital Signs, Totowa, NJ.

The Broselow/Hinkle Pediatric Emergency System is a convenience kit that contains various modules/components used for the emergency treatment of pediatric patients. The modules are color coded to accommodate patients of various sizes.
Code Information Model Numbers: 7700BIO, 7700GIO, 7700PIO, 7700RIO, 7700WIO, 7700YIO, 7700BIO2, 7700GIO2, 7700OIO2, 7700PIO2, 7700RIO2, 7700WIO2, 7700YIO2, 7730BLU5, 7730GRN5, 7730ORG5, 7730PUR5, 7730RED5, 7730WHI5, 7730YEL5, 7730FLY, 7730MOD, 7730ALS and 7730IALS; and Lot Numbers: (2008) 245F through 366F and (2009) 001K through 149K. 
Recalling Firm/
Manufacturer		 Vital Signs Inc
20 Campus Rd
Totowa NJ 07512
For Additional Information Contact Gail Rice
973-956-5392
Manufacturer Reason
for Recall		 Not compatible: The luer connector on the Intraosseus needle provided does not fit securely on the luer connection of the IV Extension Set in the module.
FDA Determined
Cause 2		 Device Design
Action Vital Signs, Inc. issued an "Urgent Medical Device Correction" letter dated June 30, 2009 to all direct and indirect accounts by first class mail. Consignees were informed of the affected device, asked to complete a Confirmation form for return and to return unused product for replacement. For further questions, contact Vital Signs, Inc. at 1-973-790-1330 extension 404.
Quantity in Commerce 23,429 kits
Distribution Worldwide Distribution -- US, Canada, United Arab Emirate, Venezuela, Guam, Korea and United Kingdom.
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.
-
-