FDA-Device2014-09-10Class I
Hip & Knee replacement pack, 900-2614, contains (1) CAUTERY TIP POLISHER UF (1) BAG SUTURE FLORAL (1) TUBE SUCTION CONNECT Y." X 12' UF (1) TABLE COVER REINFORCED 50" X 90" UF (1) MAYO STAND COVER REINFORCED UF (5) TOWELS ABSORBENT 15" X 20" UF (2) DRAPE SHEET 70" X 100" L/F (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) SKIN STAPLE 35 WIDE LIF (1) MAYO TRAY LARGE (1) TOP DRAPE WITH ADHESIVE 100" X 50" SMS STD L/F (1) BULB SYRINGE 60cc (1) UTILITY BOWL 16oz (1) UTILITY BOWL QUART 32o
Customed, Inc
Hazard
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
Sold states
Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
Affected count
1 lot (30 packed units)
Manufactured in
Calle Igualdad Final #7, Fajardo, PR, United States
Products
Hip & Knee replacement pack, 900-2614, contains (1) CAUTERY TIP POLISHER UF (1) BAG SUTURE FLORAL (1) TUBE SUCTION CONNECT Y." X 12' UF (1) TABLE COVER REINFORCED 50" X 90" UF (1) MAYO STAND COVER REINFORCED UF (5) TOWELS ABSORBENT 15" X 20" UF (2) DRAPE SHEET 70" X 100" L/F (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) SKIN STAPLE 35 WIDE LIF (1) MAYO TRAY LARGE (1) TOP DRAPE WITH ADHESIVE 100" X 50" SMS STD L/F (1) BULB SYRINGE 60cc (1) UTILITY BOWL 16oz (1) UTILITY BOWL QUART 32oz (1) INCISION DRAPE 23" X 17" (1) SKIN MARKER WITH RULER (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6 X 21 (1) YANKAUER SUCTION TUBE WITHOUT VENT UF (1) MERLING SKIN PREP APPLIC. 39ML UF (1) BLADE SURGICAL# 10 STAINLESS STEEL (1) SHEET SPLIT WITH ADHESIVE 108" X 77" UF (1) *GLOVE# 7.5 SURGEON NEUTRALON LATEX (1) * GLOVE # 8 SURGEON NEUTRALON LATEX (1) *GLOVE# 8.5 SURGEON NEUTRALON LATEX (3) GOWN IMPERVIOUS EXTRA REINFORCED XL LIF (1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL & WRAP (4) UTILITY DRAPE WITH TAPE UF (1 0) GAUZE SPONGE 4" X4" 16PL Y XRD LIF (2) BANDAGE ELASTIC WITH VELCRO 6" X 5yds (1) BLADE SURGICAL# 20 STAINLESS STEEL (2) LITE GLOVE UF (1) STOCKINETIE IMPERVIOUS 12" X 48" (1) CAUTERY PENCIL ROCKER SWITCH UF (1) BANDAGE ESMARK 6" X 9yds UF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2479-2014Don't want to check this manually?
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