FDAFDA · Food and drugs·Recall number Z-2505-2014
SHOULDER PACK CODE 900-2766 CONTENTS: (1) STAPLE SKIN 35 WIDE LIF (1) *GOBAN SELF-ADH 4" X 5YD WRAP TAN LATEX (2) U-DRAPE 60" X 70" WITAPE SPLIT 6" X 21" (1) TABLE COVER 44" X 90" (4) TOWELS ABSORBENT 15" X 20" LIF (2) TUBE SUCTION CONNECT" X 12' LIF (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF (1) BAG SUTURE FLORAL (1) SYRINGE 20cc W/0 NEEDLE LUER/LOCK LIF (1) SCALPEL WEIGHTED SAFETY #11 (1) NEEDLE SPINAL ANESTH 18G X 3% LIF (1) DRAPE INCISE ANTIMICROBIAL 23" X 17" LIF (1) CHLORAPREP 26ML APLICATOR TEAL LIF (2) ATTACHABLE POUCH BEACH CHAIR 35" X 43" WITH SUCTION PART (4) DRAPE UTILITY WITAPE L/F (4) STERI-DRAPE SMALL TOWEL DRAPE NPN-STERILE 17" X 11" LIF (1) BOWL UTILITY 32oz. (1) STOCKINETTE 6" X 48" L/F (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) WRAPPER 24" X 24" (1) NEEDLE HYPODERMIC 22G X 1 % (1) GOWN SURG REINFORCED X-LARGE TOWEL I WRAP (1) GOWN MICROCOOL IMPERV. EXTRA LONG X-LARGE (2) DRAPE ORTHOPEDIC SPLIT (1) MAYO STAND COVER REINFORCED LIF Product Usage: 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
- Code 900-2766, 6 lots 113078317 131110257 131210801 140111215 140312143 140412666
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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