Recall Z-1912-2009 ยท GAA Needle, Aspiration And Injection, Disposable
Vital Signs Inc
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
| Date | Sep 8, 2009 (initiated Jun 30, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 23,429 kits |
| Distribution | Worldwide Distribution -- US, Canada, United Arab Emirate, Venezuela, Guam, Korea and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.