Reported Sep 10, 2014 · Terminated
Breast pack TPSC, code 900-3431, contains: (1) GOWN LARGE STANDARD SMS AAMIIII (1) GOWN SOFT SMS STD. X-LARGE AAMIIII…
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 TPSC, code 900-3431
- contains(1) GOWN LARGE STANDARD SMS AAMIIII (1) GOWN SOFT SMS STD. X-LARGE AAMIIII (4) TOWELS ABSORBENT 15" X 20" LIF (1) PENCIL CAUTERY PUSH BOTTOM LIF (1) SYRINGE 60ML LUER LOCK WITHOUT NEEDLE L/F (1) TUBE SUCTION CONNECT X" X 12' LIF (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG L/F (1) COVER MAYO STAND REINFORCED LIF (2) SKIN MARKER INK WITH 8 LABEL/TIME OUT RULER LIF (2) BOWL UTILITY QUART 32oz. (1) COVER TABLE REINFORCED 50" X 90" LIF (1) RULER LIF (4) DRAPE UTILITY LIF (2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) DRAPE BREAST/CHEST SMS LIF (1) GAUZE KERLIX 4.5"X 4 1/8 YD 6PL Y L/F (2) LITE GLOVES (5) SPONGE LAP PREWASH 18" X 18" XRD LIF (1) SHEET DRAPE 42" X 57" SMS LIF (1) SHEET DRAPE 70" x 100"
- LIF Product UsageEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
- Lot codes and dates
900-34311
- lot140513333
- Amount recalled
- 1 lot/ 45 units
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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