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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:129447

Gown Cool Impervious XLGE Breathable Customed, 900-2592: (1) GOWN XL SURGICAL MICROCOOL (1) WRAPPER 24" X 24" (1) TOWELS ABSORBENT 15" X 20" LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Official recall number

Z-2477-2014

Evidence summary

Product code
LRO
Recall status
Terminated
Event initiated
May 20, 2014
Root cause
Package design/selection
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2477-2014

Field note

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