Reported Sep 10, 2014 · Terminated
ACDFPACK SURGICAL CENTER, CODE 900-2917. CONTENTS: (1) SOLUTION SURGICAL DURAPREP 6ML LIF (4) Prs. GLOVE SURG. DERMA…
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?
- ACDFPACK SURGICAL CENTER, CODE 900-2917
- CONTENTS(1) SOLUTION SURGICAL DURAPREP 6ML LIF (4) Prs. GLOVE SURG. DERMA PRENE # 8 PF LIF (3) GOWN SOFT SMS STD XL SET IN SLEEVE LIF (3) TOWELS ABSORBEN 15" X 20" UF (1) TABLE COVER REINFORCED 50" X 90" L/F (1) MAYO STAND COVER REINFORCED LIF (2) DRAPE o/.. 60" X 76" REINFORCED LIF (1)DRAPE THYROID 100" X 142" X 72" LIF (1) FLUORO COVER 30" X 30" W/RUBBAND L/F (1) DRAPE INCISE IOBAN 13" X 13" (2) LITE GLOVE LIF (2) TUBE SUCTION CONNECT. W X 12' LIF (12) TOWELS CLOTH HUCK BLUE LIF (1) UTILITY BOWL 16oz LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) SKIN MARKER W/RULER LIF (9) LABELS FOR SKIN MARKERS 1.25
- X Y! (1) RULER (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF (2) SYRINGE 20cc W/0 NDL LUER LOCK LIF (2) SYRINGE 3cc W/0 NDL LUER LOCK LIF (1) BULB SYRINGE 60cc
- LIF (3) NEEDLE HYPODERMIC 18G X 1Y! LIF (1) NEEDLE 30G X 1 DISP. L/F (1) NEEDLE SPINAL ANESTH 18G X 3W' LIF (2) BLADE SURGICAL# 15 CARBON STEEL (1) TIME OUT BEACON NON WOVEN LIF (2) TAPE TEGADERM 2 3/8 "X 2 o/.. "L/F (2)
- MEDICINE CUP 2oz LIF Product UsageEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
- Lot codes and dates
- Code 900-2917, 6 lots 113047022 113057702 113068036 113078732 113109798 140312146
- Amount recalled
- 6 lots, 180 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Customed, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.