FDA Recall

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, 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. 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. Recall # Z-1912-2009
CODE
Lot Numbers: (2008) 245F through 366F and (2009) 001K through 149K
RECALLING FIRM/MANUFACTURER
Vital Signs, Inc., Totowa, NJ, by letter dated June 30, 2009. Firm
initiated recall is ongoing.
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.
VOLUME OF PRODUCT IN COMMERCE
23,429 units
DISTRIBUTION
Nationwide, Canada, United Arab Emirate, Venezuela, Guam, Korea and
United Kingdom



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