FDAFDA · Food and drugs·Recall number Z-2489-2014
Liposuction Pack MRT, code 900-2656, contains: (1) NEEDLE HYPODERMIC 27 X 1 LIF (1) UTILITY BOWL QUART 32oz LIF (1) MAYO STAND COVER REINFORCED LIF (2) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE LIF ( 1) PVP SCRUB SOLUTION 4oz BOTTLE (20) GAUZE SPONGES 4 X 4 (12) TOWEL CLOTH HUCK (BLUE) (4) TOWEL CLAMP (3) TIP ABSORBENT APPLICATOR STICK SPONGE LIF ( 1) SAFETY SCALPEL 15 (3) DRAPE SHEET 70 X 100 LIF (2) TOWEL ABSORBENT 15 X 20 LIF (2) TABLE COVER REINFORCED 44 X 78 LIF (1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER LIF (1) DENTURE CUP 8oz WITH LID (2) SYRINGE 10ML W/FIXED M/L DARK GREEN (1) TUBING INFILTRATION PERISTALTIC PUMPS (2) LITE GLOVES L/F 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 900-2656, 1 lot: 140111441
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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