FDA-Device2014-09-10Class I
OPHTALMIC PACK - (1) GOWN LGE SMS NON REINF TIWRAP (1) IODINE POVIDONE 1oz. (2) TOWEL ABSORBENT 15" x 20" UF (1) SYRINGE 3cc W/NEEDLE 21 G X 1 Y. UF (6) COTION TIP APPLICATOR 6" WOOD (1) TABLE COVER REINFORCED 50" X 90" UF (1) PAD EYE 2 1/8 X 2 5/8 (1) CYSTOTOMO IRRIG. PEARCE 25G X 5/8 (1) SHIELD EYE UNIVERSAL (1) Pr. GLOVES SURG.# 7% LATEX (10) SPONGE EYE SPEAR MICRO (1) SYRINGE 1cc TUBER. 25G X 5/8 SITIP UF (10) GAUZE SPONGES 4" X 4" 12PL Y (1) Pr. GLOVES SURG. 8 POWD
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
25 lots; 2382 units (multiple units per lot)
Manufactured in
Calle Igualdad Final #7, Fajardo, PR, United States
Products
OPHTALMIC PACK - (1) GOWN LGE SMS NON REINF TIWRAP (1) IODINE POVIDONE 1oz. (2) TOWEL ABSORBENT 15" x 20" UF (1) SYRINGE 3cc W/NEEDLE 21 G X 1 Y. UF (6) COTION TIP APPLICATOR 6" WOOD (1) TABLE COVER REINFORCED 50" X 90" UF (1) PAD EYE 2 1/8 X 2 5/8 (1) CYSTOTOMO IRRIG. PEARCE 25G X 5/8 (1) SHIELD EYE UNIVERSAL (1) Pr. GLOVES SURG.# 7% LATEX (10) SPONGE EYE SPEAR MICRO (1) SYRINGE 1cc TUBER. 25G X 5/8 SITIP UF (10) GAUZE SPONGES 4" X 4" 12PL Y (1) Pr. GLOVES SURG. 8 POWDER LATEX (1) MAYO STAND COVER REINFORCED UF (1) BLADE 15D WITH HANDLE (STABKNIFE) (1) EYE DRAPE (1) GOWN LARGE STANDARD SMS (1) TRAY 3/COMPART (1) BAG ZIP LOCK (1) ANGLED FULL HANDLE (1 ) Pr. GLOVES SURGICAL# 6% LATEX 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-2412-2014Don't want to check this manually?
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