Recall Z-1912-2009
Vital Signs Inc · initiated June 30, 2009
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.
Codes / lots: 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.
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: Device Design
Action taken
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.
Details
- Recall number
- Z-1912-2009
- Initiated
- June 30, 2009
- Posted by FDA
- September 8, 2009
- Terminated
- August 27, 2012
- Product code
- GAA – Needle, Aspiration And Injection, Disposable
- Quantity
- 23,429 kits
- Distribution
- Worldwide Distribution -- US, Canada, United Arab Emirate, Venezuela, Guam, Korea and United Kingdom.
- Recalling firm
- Vital Signs Inc, Totowa, NJ