FDAFDA · Food and drugs·Recall number Z-2481-2014
Shoulder Pack, Code 900-2616, contains: (2) TUBE SUCTION CONNECT Y."X12' UF (1) SYRINGE 20CC W/0 NDL UL UF (2) DRAPE VIDEO CAMERA UF (1) COVER MAYO STAND REINF. UF (5) SPONGE LAP. PRE-WASH XRD UF (1) DRAPE U 60" X 70" WIT APE UF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD UF (1) DRAPE BEACH CHAIR SHOULDER UF (1) CO BAN WRAP 4"X5 YRD LATEX (1) GOWN IMP. XTRA REINF. X-LGE UF (1) TUR Y SET 81" 2.1M REG. CLAM (1) GOWN IMP. POL YREINF XLGE T/WRAP UF (1) TABLE COVER REINF. 50" X 90" UF 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
- 900-2616, 4 lots: 112083077 113109907 131110339 140312139
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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