Reported Sep 10, 2014 · Terminated

Liposuction Pack MRT, code 900-2656, contains: (1) NEEDLE HYPODERMIC 27 X 1 LIF (1) UTILITY BOWL QUART 32oz LIF (1)…

Customed, Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Customed, Inc · Calle Igualdad Final #7 · Fajardo, PR · 00738

Is this the product you have?

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 UsageEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents

Lot codes and dates: Code 900-2656
1
lot140111441
Amount recalled: 1 lot / 25 units, multiple units per lot

This recall covers 233 products

The agency filed one notice per product. You are reading one of them; the other 232 are below.

220 more are in the archive.

Where it was sold

Nationwide
FL
PR

Why it was recalled

Stop using this product now

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.

Using this product could cause serious injury, illness or death — stop using it now.

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By hazard

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Where it was distributed

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