Reported Sep 10, 2014 · Terminated
Face Pack MRT, product code 900-2654, contains: (2) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE LIF (2) TOWELS ABSORBENT 15…
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?
- Face Pack MRT, product code 900-2654
- contains(2) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE LIF (2) TOWELS ABSORBENT 15 X 20 LIF (1) DRAPE INST. MAGNETIC 10 X 16 LIF (1) TRAY HALF DEEP (1) COVER MAYO STAND REINFORCED LIF (1) SHEET ENT SPLIT 110 X 77 SMS LIF (1) COVER TABLE REINFORCED 44" X 78" LIF (20) GAUZE SPONGES 4 X 4 12PLY L/F (6) TOWELS CLOTH HUCK C BLUE L/F (2) TIP ABSORB. APPLIC STICK SPONGE LIF (1) STRIP STERI CLOSURE LIF (1) CUP DENTURE 8oz. TEAL WITH LID (1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER LIF (2) SYRINGE 10ML DARK GREEN (1) SYRINGE 10ML YELLOW L/F (1) LITE GLOVE LIF (1) COUNTER NEEDLE &
- BLADE 20C FOAM/MAG LIF Product UsageEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
- Lot codes and dates
900-26542
- lots112062214 112093599
- Amount recalled
- 2 lots/ 112 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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