FDAFDA · Food and drugs·Recall number Z-2459-2014
08 PAD PACK II (2,3) CUSTOMED CONTENTS: (3) TOWEL ABSORBENT 15" X 20" (1) BOWL W/LID PLASTIC 80oz (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) SHEET PLASTIC 44" X 65" (1) DRAPE UNDERBUTTOCK W/POUCH (1) UMBILICAL CORD CLAMP (1) BABY BLANKET 30" X 30" POLY ABSOR.IMP. (1) PACKING VAGINAL XRD 4" X 36" 8PLY (10) GAUZE SPONGE 4" X 4" 16PLY XRD (1) DRAPE ABDOMINAL WITAPE 40" X 54" (2) LEGGINS W/7'' CUFF 30" X 42" (1) TABLE COVER REINFORCED 44" X 78" (2) PAD OBSTETRICAL XL (1) EAR ULCER SYRINGE 2oz. 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
- Product code 900-2464 ,3 lots 112020343 112051958 112083317
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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