FDAFDA · Food and drugs·Recall number Z-2428-2014
GENERAL PACK - CONTENTS: (4) ABSORBENT TOWEL 15" x 20" LIF (1) MAYO STAND COVER REINFORCED LIF ( 1) NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF (2) UTILITY BOWL 16 oz. LIF (1) GLASINE BAG PLAIN ( 1) SUTURE BAG FLORAL (4) DRAPE UTILITY WITH TAPE LIF ( 1) TABLE COVER REINFORCED 50" X 90" LIF (1) SURGICAL BLADE# 10 STAINLESS STEEL ( 1) SURGICAL DURAPREP SOLUTION 26mL LIF ( 1) LAPAROTOMY T DRAPE STD SMS (2) DRAPE SHEET 41" X 58" SMS LIF (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS LIF (1 0) GAUZE 4"X 4" X 4 PLY ( 1) CAUTERY TIP POLISHER LIF (5) LAP SPONGES PRE-WASH XRD LIF ( 1) CAUTERY PENCIL ROCKER SWITCH LIF (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF ( 1) TUBE SUCTION CONNECT. 3/16" X 12' LIF ( 1) SURGICAL BLADE# 15 CARBON STEEL ( 1) CONTAINER SPECIMEN 4 oz. WITH LID & LABEL 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 differ 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 900-2003, 29 lots: 112030702 112041277 112062472 112093923 112103923 112114386 112114472 112125311 113015438 113025954 113026205 113036457 113047011 113047156 113057447 113057696 113057814 113068159 113078779 113089205 113099569 131110221 131110405 131110582 140211725 140211874 140312378 140312461 140412832
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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