Reported Sep 10, 2014 · Terminated
REEMPLAZO DE RODILLA Y CADERA CONTENTS
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?
REEMPLAZO DE RODILLA Y CADERA CONTENTS
8 of 8 products
| Model / number | Product as published |
|---|---|
(2) | SKIN MARKERINK W/8 LABEIJfiME OUT/RULER (I) BAG SUTURE FLORAL |
(2) | TIME OUT BEACON NON WOVEN (2) DRAPE U 60" X 70"WI TAPE SPLIT 6" X 21 " |
(2) | TUBE SUCTION CONNECT'/.'' X 12' (2) DRAPE INCISE ANTIMICROBIAL 23" X 17" |
(4) | LIGHT SHIELD (I) NEEDLE SPINAL ANESTH 18G X 3 Y |
(2) | COUNTER NEEDLE 60C FOAM STRIP/MAG STRIP (I) YANKAUER OPEN TIP CLEAR W/0 CIV |
(2) | NEEDLE BLUNT FILL 1 8G X I Y, (2) COVER TABLE BTC 77" X I I 0"l-ID FULL COVERAGE |
(3) | COVER MAYO STAND W/CSR 23" X 54" (I) BOWL UTILITY QUART 32oz. |
(3) | CLAMP TOWEL (I) BOWL UTILITY PINT 16oz. |
- Lot codes and dates
- Code 900-27267 lots 131110255 131210799 140111086 140211664 140312141 140412664 140512992
- Amount recalled
- 7 lots,208 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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