FDAFDA · Food and drugs·Recall number Z-2316-2014
LAPAROTOMY PACK - (I) UTILITY BOWL 16oz ( I) ELECTRODE DUAL DEPRES./GROUNDPAD (I) UTILITY BOWL 32oz ( I) GOWN IMP. REINFORCED XL SMS AAMI Ill (2) NEEDLE & BLADE COUNTER I OC MAG/CLEAR ( I) DRAPE LAPAROT ABDOM WITH POUCH (2) TOWELS ABSORBENT 15" x 20" ( I) TIME OUT BEACON NON WOVEN (4) DRAPE UTILITY (I) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (I) MAYO STAND COVER REINFORCED ( I) SUTURE BAG FLORAL (I) TABLE COVER REINFORCED 50" X 90" ( I) GOWN IMP EXTRA REINF LGE TOWEUWRAP (2) DRAPE SHEET 42" X 55" SMS (I) CAUTERY TIP POLISHER (I) CAUTERY PENCIL ROCKER SWITCH ( I) BAG GLASSINE (I) SURGICAL BLADE# 10 STAINLESS STEEL 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 900-281A, 3 lots: 140312027 140412669 140412796
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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