Reported Sep 10, 2014 · Terminated
CERVICAL PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER TABLE REINFORCED 50" X 90" (1) COVER FLUORO 30" 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?
11 of 11 products
| Model / number | Product as published |
|---|---|
(1) | CERVICAL PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS |
(1) | COVER TABLE REINFORCED 50" X 90" |
(1) | COVER FLUORO 30" X 30" WITH RUBBER BAND (8) TOWELS CLOTH HUCK BLUE |
(1) | SHEET :Y. 60" X 77" DRAPE REINFORCED (10) GAUZE SPONGE 4" X 4" 16PLY XRD |
(1) | SKIN MARKER W/RULER (1) DRAPE THYROID 100" X 142" X 72" |
(1) | TAPE TEGADERM 2-3/8 X 2-3/4 (1) SOLUTION SURGICAL DURAPREP 6ML |
(2) | STERI-STRIP COMPOUND BENZOIN TINT 2/3cc VI (1) NEEDLE 30G X 1 DISP |
(2) | GAUZE SPONGE 2" X 2" 4PLY NON WOVEN (1) STRIP STERI CLOSURE %'' X 4" |
(1) | GOWN SOFT SMS STD XL SET IN SLEEVE (4) NEEDLE HYPODERMIC 18G X 1 % |
(1) | RULER FLEXIBLE PLASTIC (4) SYRINGE 3CC WITHOUT NEEDLE LUER LOCK |
(9) | BAG ZIP LOCK (1) STRIP STERI DRAPE LARGE 17" X 23" |
- Lot codes and dates
Product code 900-22862 lots 112082968 113057620
- Amount recalled
- 2 lots/160 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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