FDA-Device2014-09-10Class I
IMPLANTE DE ORTHOPEDIA- 1) GOWN IMPERV. XTRA REINF. XL SMS T/WRAP LEVEL IV (1) CAUTERY TIP POLISHER LIF (1) DURAPREP SURGICAL SOLUTION 26ml LIF (1) BAG SUTURE FLORAL LIF (1) TUBE SUCTION CONNECT. Y.!" X 12' L/F (1) CAUTERY PENCIL ROCKER SWITCH LIF (2) *Pr. SURGEON NEUTRALON GLOVE# 8 LATEX (2) BLADE SURGICAL# 10 STAINLESS STEEL (1) BAG GLASSINE (1) STOCKINETIE IMPERVIOUS 14" X 48" LIF (2) LITE GLOVE LIF (1) SPLIT SHEET W/ADHES 108" X 77" STD SMS UF (1) MAYO STAND COVER REINFORC
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
16 lots; 1041 units (multiple units per lot)
Manufactured in
Calle Igualdad Final #7, Fajardo, PR, United States
Products
IMPLANTE DE ORTHOPEDIA- 1) GOWN IMPERV. XTRA REINF. XL SMS T/WRAP LEVEL IV (1) CAUTERY TIP POLISHER LIF (1) DURAPREP SURGICAL SOLUTION 26ml LIF (1) BAG SUTURE FLORAL LIF (1) TUBE SUCTION CONNECT. Y.!" X 12' L/F (1) CAUTERY PENCIL ROCKER SWITCH LIF (2) *Pr. SURGEON NEUTRALON GLOVE# 8 LATEX (2) BLADE SURGICAL# 10 STAINLESS STEEL (1) BAG GLASSINE (1) STOCKINETIE IMPERVIOUS 14" X 48" LIF (2) LITE GLOVE LIF (1) SPLIT SHEET W/ADHES 108" X 77" STD SMS UF (1) MAYO STAND COVER REINFORCED LIF (4) DRAPE UTILITY WITH TAPE LIF (5) ABSORBENT TOWELS 15" X 20" LIF (5) LAP SPONGES PRE-WASH XRD LIF (2) DRAPE SHEET 70" X 100" STD SMS LIF (1) MAYO TRAY LARGE (2) * Pr. SURGEON NEUTRALON GLOVE #8% LATEX (1) STAPLE SKIN WIDE 35 ST. LIF (1) TOP DRAPE W/ADHES. 108" X 50" STD SMS LIF (1) BULB SYRINGE 60cc (2) BANDAGE ELASTIC 6" X 5"yds LIF (2) UTILITY BOWL 32oz (1) UTILITY BOWL 16oz LIF (1) SKIN MARKER WITH RULER (1) INCISE DRAPE ANTIMICROBIAL 23" X 17" LIF (2) ABDOMINAL PAD 8" X 7 W (1) U-DRAPE 60" X 70" WIT APE SPLIT 6" X 21' (2) GOWN IMPERVIOUS REINFORCED XL (1) YANKAUER SUCTION TUBE WITHOUT VENT UF (2) COVER TABLE BTC 77" X 86" HD FULL COVERAGE 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-2346-2014Don't want to check this manually?
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