Reported Sep 10, 2014 · Terminated
Tummy Tuck Pack- FJG, code 900-3114, contains: (2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWEL ABSORBENT…
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?
- Tummy Tuck Pack- FJG, code 900-3114
- contains(2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWEL ABSORBENT 15" X 20" (1) PENCIL CAUTERY PUSH BOTIOM ST. HOLSTER (1) NEEDLE HYPODERMIC 22G X 1 Y2 (2) SYRINGE 20CC WITHOUT NEEDLE LUER LOCK (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG (2) BOWL UTILITY QUART 32oz. (1) COVER MAYO STAND REINFORCED (2) MARKER SKIN WITH RULER (1) RULER (1) COVER TABLE REINFORCED 50" X 90" (2) CUP DENTURE 8oz TEAL WITH LID (6) TOWEL CLOTH HUCK BLUE (1) TUBE SUCTION CONNECT X" X 12' (1) YANKAUER SUCTION TUBE WITHOUT VENT (1) SHEET% DRAPE REINFORCED 60" X 77" (4) DRAPE UTILITY WITH TAPE (1 0) LAP SPONGE PREWASH 18" X 18" XRD (1) BLADE SURG. #15 CARBON STEEL (1) BLADE SURG. #1 0 CARBON STEEL (1) SYRINGE BULB 60cc (2) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #6.5 P/F (2) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #7 P/F (1) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #7.5 P/F (1) SKIN STAPLE 35 WIDE (1) DRAPE TOP WITH ADHESIVE 108" X 50" STD SMS (2) DRAPE SIDE 42" X 76" WITH TAPE (1) DRAPE BOTIOM ABS REINFORCED 71" X 62" STD SMS WITH TAPE (1 0) GAUZE SPONGE 4" X 4" 16 PLY (1) PK. STRIP STERI CLOSURE W X 4"
- Product UsageEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
- Lot codes and dates
900-31142
- lots131210804 140111438
- Amount recalled
- 2 lots/48 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
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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