Reported Sep 10, 2014 · Terminated

Breast Pack BOD, code 900-3029, contains: (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWEL ABSORBENT 15" X…

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?

Breast Pack BOD, code 900-3029
contains(2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWEL ABSORBENT 15" X 20" (1) PENCIL CAUTERY PUSH BOTTOM (1) SYRINGE BULB 60CC (1) TUBE SUCTION CONNECT%" X 12' (1) COUNTER NEEDLE/BLADE 20C FOAM/MAG (1) BOWL UTILITY QUART 32oz TURQ (1) COVER MAYO STAND REINFORCED (1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER (1) COVER TABLE REINFORCED 50" X 90" (1) CUP DENTURE 8oz TEAL WITH LID (1) RULER (6) TOWEL CLOTH HUCK BLUE (2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK (1) YANKAUER SUCTION TUBE WITHOUT VENT (1) DRAPE BREAST/CHEST (2)
LITE GLOVE Product UsageEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents

Lot codes and dates: 900-3029
3
lots113099554 140312149 140613789
Amount recalled: 3 lots/ 60 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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