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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:129510

Plastic Pack Customed, code 900-2582 (1) GOWN LGE SMS IMP REINF L/F (1) GOWN SURG. REINF LGE TMJRAP LIF (1) MAYO STAND COVER REINF LIF (1) TABLE COVER REINF 50" X 90" LIF (4) (1) PVP PAINT 8" STICK SPONGE (2) DRAPESHEET 41X A¿MED LIF (3) TOWELS ABSORBENT 15 X 20 LIF (2)DRAPE UTILITY Rape LIF (1) BLADE SURGICAL15 S/STEEL (10) GAUZE SPONGE 4 X 4 16 PL Y (20) APPLICATOR COTOIN 6 WOOD Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Official recall number

Z-2487-2014

Evidence summary

Product code
LRO
Recall status
Terminated
Event initiated
May 20, 2014
Root cause
Package design/selection
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2487-2014

Field note

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