ACDFPACK SURGICAL CENTER, CODE 900-2917. CONTENTS: (1) SOLUTION SURGICAL DURAPREP 6ML LIF (4) Prs. GLOVE SURG. DERMA PRENE # 8 PF LIF (3) GOWN SOFT SMS STD XL SET IN SLEEVE LIF (3) TOWELS ABSORBEN 15" X 20" UF (1) TABLE COVER REINFORCED 50" X 90" L/F (1) MAYO STAND COVER REINFORCED LIF (2) DRAPE o/.. 60" X 76" REINFORCED LIF (1)DRAPE THYROID 100" X 142" X 72" LIF (1) FLUORO COVER 30" X 30" W/RUBBAND L/F (1) DRAPE INCISE IOBAN 13" X 13" (2) LITE GLOVE LIF (2) TUBE SUCTION CONNECT. W X 12' LIF (12) TOWELS CLOTH HUCK BLUE LIF (1) UTILITY BOWL 16oz LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) SKIN MARKER W/RULER LIF (9) LABELS FOR SKIN MARKERS 1.25 X Y:! (1) RULER (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF (2) SYRINGE 20cc W/0 NDL LUER LOCK LIF (2) SYRINGE 3cc W/0 NDL LUER LOCK LIF (1) BULB SYRINGE 60cc LIF (3) NEEDLE HYPODERMIC 18G X 1Y:! LIF (1) NEEDLE 30G X 1 DISP. L/F (1) NEEDLE SPINAL ANESTH 18G X 3W' LIF (2) BLADE SURGICAL# 15 CARBON STEEL (1) TIME OUT BEACON NON WOVEN LIF (2) TAPE TEGADERM 2 3/8 "X 2 o/.. "L/F (2) MEDICINE CUP 2oz LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Enforcement
- Recall Number
- Z-2511-2014
- 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
ACDFPACK SURGICAL CENTER, CODE 900-2917. CONTENTS: (1) SOLUTION SURGICAL DURAPREP 6ML LIF (4) Prs. GLOVE SURG. DERMA PRENE # 8 PF LIF (3) GOWN SOFT SMS STD XL SET IN SLEEVE LIF (3) TOWELS ABSORBEN 15" X 20" UF (1) TABLE COVER REINFORCED 50" X 90" L/F (1) MAYO STAND COVER REINFORCED LIF (2) DRAPE o/.. 60" X 76" REINFORCED LIF (1)DRAPE THYROID 100" X 142" X 72" LIF (1) FLUORO COVER 30" X 30" W/RUBBAND L/F (1) DRAPE INCISE IOBAN 13" X 13" (2) LITE GLOVE LIF (2) TUBE SUCTION CONNECT. W X 12' LIF (12) TOWELS CLOTH HUCK BLUE LIF (1) UTILITY BOWL 16oz LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) SKIN MARKER W/RULER LIF (9) LABELS FOR SKIN MARKERS 1.25 X Y:! (1) RULER (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF (2) SYRINGE 20cc W/0 NDL LUER LOCK LIF (2) SYRINGE 3cc W/0 NDL LUER LOCK LIF (1) BULB SYRINGE 60cc LIF (3) NEEDLE HYPODERMIC 18G X 1Y:! LIF (1) NEEDLE 30G X 1 DISP. L/F (1) NEEDLE SPINAL ANESTH 18G X 3W' LIF (2) BLADE SURGICAL# 15 CARBON STEEL (1) TIME OUT BEACON NON WOVEN LIF (2) TAPE TEGADERM 2 3/8 "X 2 o/.. "L/F (2) MEDICINE CUP 2oz LIF 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.
Code 900-2917, 6 lots 113047022 113057702 113068036 113078732 113109798 140312146
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.
6 lots, 180 units (multiple units per lot)