Broselow/Hinkle Pediatric Emergency System; Contents: 1 15 Ga Adjustable Length Sternal/Iliac aspiration Needle; 1 Exten
FDA device recall Z-1912-2009 · posted 2009-09-08 · Terminated
Recall details
- Recalling firm
- Vital Signs Inc
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GAA
- Quantity affected
- 23,429 kits
- Distribution
- Worldwide Distribution -- US, Canada, United Arab Emirate, Venezuela, Guam, Korea and United Kingdom.
- Date initiated
- 2009-06-30
- Date posted
- 2009-09-08
- Date terminated
- 2012-08-27
- Location
- Totowa, NJ
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