FDA-Device2014-09-10Class I
Arthroscopy Pack,900-2609, contains: (5) LAP SPONGE PREWASH 18" X 18" XRD (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH (3) STRIPS TAPE 24" X 4" (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (4) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) TUBE SUCTION CONNECT Y4" X 12' (2) ELASTIC BANDAGE WITH VELCRO 6" X 5yds (10) GAUZE SPONGE 4" X 4" 16PLY XRD (1) MERLING SKIN PREP. APPLIC 39ML (1) CAST PADDING COTTON ROLL 2" X 4yds (1) SKIN MARKER WITH RULER (1) BLADE SURGICAL# 11 CARBON
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
7 lots (9 packs per lot, 63 packs)
Manufactured in
Calle Igualdad Final #7, Fajardo, PR, United States
Products
Arthroscopy Pack,900-2609, contains: (5) LAP SPONGE PREWASH 18" X 18" XRD (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH (3) STRIPS TAPE 24" X 4" (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (4) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) TUBE SUCTION CONNECT Y4" X 12' (2) ELASTIC BANDAGE WITH VELCRO 6" X 5yds (10) GAUZE SPONGE 4" X 4" 16PLY XRD (1) MERLING SKIN PREP. APPLIC 39ML (1) CAST PADDING COTTON ROLL 2" X 4yds (1) SKIN MARKER WITH RULER (1) BLADE SURGICAL# 11 CARBON STEEL (1) GOWN SURG REINFORCED LGE TOWEL WRAP (2) GOWN XL SMS IMPERVIOUS REINFORCED (2) LITE GLOVE (1) STOCKINETTE IMPERVIOUS 12" X 48" (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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2478-2014Don't want to check this manually?
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