FDAFDA · Food and drugs·Recall number Z-2510-2014
BASIC COSMETIC SURG. PACK CUSTOMED (USA), CODE 900-2915. CONTENTS: (2) TOWELS ABSORBENT 15" X 20" LIF (1) DRAPE BREAST/CHEST SMS L/F (1) SYRINGE 20cc W/0 NEEDLE LUER LOCK LIF (1) TUBE SUCTION CONNECT Yt" X 12' LIF (1) YANKAUER SUCTION TUBE W/0 VENT L/F (1) STERI STRIP CLOSURE%" X 4" L/F (1) BLADE SURG. #15 CARBON STEEL (1) NEEDLE HYPODERMIC 25 X 1 % LIF (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) PENCIL CAUTERY ROCKER SWITCH W/ HOLSTER LIF (1) SYRINGE 60cc THUMB CONT. RING CATH. TIP LIF (1) COVER TABLE REINFORCED 50" X 90" LIF (1) COVER MAYO STAND REINFORCED LIF (1) BAG SUTURE FLORAL (2) GOWN SOFT SMS STD. XL SET IN SLEEVE LIF (4) DRAPE UTILITY WITH TAPE L/F (4) TOWEL CLOTH HUCK LIF (1) WRAPPER 24" X 24" 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 900-2915, 4 lots 113026307 113047021 113068035 113078731
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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