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

Products covered by this recall
Model / numberProduct 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 14, 2017 · Data as of Sep 19, 4:45 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.