OPHTALMIC PACK- (1) TABLE COVER REINF. 44" X 78" UF (1) GOWN SMS XLGE STD UF (2) TOWEL ABSORBENT 15" X 20" LIF (1) SYRINGE 3cc W/0 NDL LILOCK UF (1) MAYO STAND COVER REINF. LIF (1) NEEDLE HYPODERMIC 18G X 1% ST. UF (10) EYE MICRO SPONGE UF (2) LABEL CONTRAST BLUE (1) GOWN LGE STD SMS (1) WIPE INSTRUMENT 1MM (1) EYE DRAPE UF (1) LABEL XYLOCAINE FOR MEDICATION YELLOW (1) IODINE POVIDONE 1oz. (1) EYE SHIELD UNIVERSAL L/F (10) APPLICATOR COTION 6" WOOD (1) BALANCED SALT SOLUTION 18ML LIF (10) GAUZE SPONGE 4" X 4" 12P Y UF (1) LABEL BSS (1) TRAY 3/COMPARTMENT LIF (1) LABEL EPINEPHRINE VIOLET/WHITE (1) LABEL IODINE WHITE/BLACK Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Enforcement
- Recall Number
- Z-2420-2014
- Event ID
- 68536
- Classification
- Class I
- Status
- Terminated
- Product Type
- Devices
- Firm
- Customed, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 10, 2014
- Initiation Date
- May 20, 2014
- Classification Date
- August 29, 2014
- Termination Date
- August 14, 2017
- Address
- Calle Igualdad Final #7, Fajardo, PR, 00738, United States
Description
OPHTALMIC PACK- (1) TABLE COVER REINF. 44" X 78" UF (1) GOWN SMS XLGE STD UF (2) TOWEL ABSORBENT 15" X 20" LIF (1) SYRINGE 3cc W/0 NDL LILOCK UF (1) MAYO STAND COVER REINF. LIF (1) NEEDLE HYPODERMIC 18G X 1% ST. UF (10) EYE MICRO SPONGE UF (2) LABEL CONTRAST BLUE (1) GOWN LGE STD SMS (1) WIPE INSTRUMENT 1MM (1) EYE DRAPE UF (1) LABEL XYLOCAINE FOR MEDICATION YELLOW (1) IODINE POVIDONE 1oz. (1) EYE SHIELD UNIVERSAL L/F (10) APPLICATOR COTION 6" WOOD (1) BALANCED SALT SOLUTION 18ML LIF (10) GAUZE SPONGE 4" X 4" 12P Y UF (1) LABEL BSS (1) TRAY 3/COMPARTMENT LIF (1) LABEL EPINEPHRINE VIOLET/WHITE (1) LABEL IODINE WHITE/BLACK Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
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.
Product code 900-1933, 20 lots: 112114613 112125046 113015506 113025815 113036476 113046936 113047008 113057440 113057613 113057842 113078288 113078581 113089021 113099282 113109641 131110072 131110603 131210966 140412831 140513465
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.
20 lots; 1812 units (multiple units per lot)