Devices

Device Recall Broselow/Hinkle Pediatric Emergency System

Model / Serial
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.
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution -- US, Canada, United Arab Emirate, Venezuela, Guam, Korea and United Kingdom.
Product Description
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.
Manufacturer
Vital Signs Inc
1 Event
- Recall of Device Recall Broselow/Hinkle Pediatric Emergency System

Manufacturer

Vital Signs Inc

Manufacturer Address
Vital Signs Inc, 20 Campus Rd, Totowa NJ 07512
Manufacturer Parent Company (2017)
Vyaire Holding Company
Source
USFDA

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