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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:129555

Basic Pack FPSC Florham Pack , code 900-2969, contains: (1) COVER TABLE REINFORCED 50" X 90" (10) GAUZE SPONGE 4" X 4" 16 PLY XRD (1) COVER MAYO STAND REINFORCED (2) GOWN SOFT SMS STD. X-LARGE AAMI Ill (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG (2) TOWELS ABSORBENT 15" X 20" (4) DRAPE UTILITY WITH TAPE (1) WRAPPER 24" X 24" (8) LABELS FOR SKIN MARKERS 1.25" X %" (2) LITES GLOVE (1) MARKER SKIN WITH RULER (1) BLADE SURGICAL# 15 CARBON STEEL (1) RULER (5) SPONGE LAP PREWASH 18" X 18" XRD Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Official recall number

Z-2516-2014

Evidence summary

Product code
LRO
Recall status
Terminated
Event initiated
May 20, 2014
Root cause
Package design/selection
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2516-2014

Field note

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