Device evidence

device-recall:cfres:129431

LAPAROSCOPY ABO PACK (1) (2) CUSTOMED CONTENTS: (1) GOWN SURG. REINFORCED X-LARGE TOWEL I WRAP (2) TOWELS ABSORBENT 15" X 20" (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED (4) DRAPE UTILITY WITH TAPE (1) SUTURE BAG FLORAL (1) DRAPE LAPAROSCOPY CHOLE W/TROU (1) TABLE COVER REINFORCED 50" X 90" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Official recall number

Z-2466-2014

Evidence summary

Product code: FDE
Recall status: Terminated
Event initiated: May 20, 2014
Root cause: Package design/selection
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-2466-2014