FDAFDA · Food and drugs·Recall number Z-2328-2014
LAPAROSCOPY~OBPACK - (4) ABSORBENT TOWELS 15" x 20" LIF (2) LEGGINS WITH 7" CUFF (1) LAPAROSCOPY T SHEET SMS (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) NEEDLE HYPODERMIC 18G X 1% (1) *ROBIN REDRUBBER CATHETER 14FR LATEX (1) DRAPE LASER CAMERA W/EL LIF (1) PAD OBSTETRICAL X-LARGE 6" X 96" LIF (3) TOWEL CLAMP (4) DRAPE UTILITY WITH TAPE LIF (1) GOWN SURGICAL POLY REINFORCED BREATHABLE IMP LARGE LEVEL IV (2) GOWN SURG POLY REINFORCED BREATHABLE IMP XL SMS LEVEL IV (20) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) TABLE COVER 44" X 90" (1) MAYO STAND COVER REINFORCED LIF (1) SURGICAL BLADE #15 CARBON STEEL (1) LITE GLOVE LIF (1) DRESSING NON-ADHESIVE TELFA 4" X 3" (1) TUBE SUCTION CONNECT Y4" X 12' LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
Published September 10, 2014 · Recall initiated: May 20, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Customed, Inc
- Distributor
- 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.
- Lot
- Product code 900-484, 25 lots: 110112811 110123129 111010130 111030679 111040976 111051201 111071818 111082100 111092392 111092547 111123258 112020476 112041331 112072873 112083432 112093945 113026060 113026073 113036489 113036802 113067928 113088868 113109845 131210819 140211845
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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