Reported Sep 10, 2014 · Terminated
ORTHOPEDIC IMPLANT PACK CUSTOMED USA, CODE 900-2903 CONTENTS: (1) CAUTERY TIP POLISHER UF (1) SKIN MARKER W/RULER (1)…
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?
13 of 13 products
| Model / number | Product as published |
|---|---|
(1) | CUSTOMED USA, CODE 900-2903 CONTENTS: (1) CAUTERY TIP POLISHER UF |
(1) | SKIN MARKER W/RULER (1) BAG SUTURE FLORAL |
(2) | U - DRAPE 60" X 70" WITAPE SPLIT 6" X 21" (1) TUBE SUCTION CONNECT W' X 12' UF |
(1) | PAD ABDOMINAL 8" X 7.5" (1) BAG GLASSINE |
(1) | YANKAUER SUCTION TUBE W/0 VENT LIF (2) LITE GLOVE UF |
(1) | SOLUTION SURGICAL DURAPREP 26ML LIF (2) TABLE COVER REINFORCED 50" X 90" LIF (1) BLADE SURGICAL# 10 STAINLESS STEEL (1) MAYO STAND COVER REINFORCED LIF |
(1) | SHEET SPLIT W/ADHES 108" X 77" STD SMS L/F (5) TOWELS ABSORBENT 15" X 20" UF |
(1) | STOKINETIE IMPERVIOUS 14" X 48" LIF (2) DRAPE SHEET 70" X 100" LIF (1) *GLOVE# 7'!h SURGEON NEUTRALON LATEX (5) LAP SPONGE PREWASH 18" X 18" XRD LIF |
(1) | *GLOVE # 8 SURGEON NEUTRALON LATEX (1) SKIN STAPLE 35 WIDE UF |
(1) | *GLOVE# 8'!h SURGEON NEUTRALON LATEX (1) TRAY MAYO LGE |
(1) | GOWN SURG REINFORCED XL TOWEUWRAP (1) DRAPE TOP W/ADHES 108" X 50" STD SMS UF (2) GOWN XL SMS IMPERVIOUS REINFORCED UF (1) BULB SYRINGE 60cc CLEAR |
(1) | CAUTERY PENCYL ROCKER SWITCH UF (1) UTILITY BOWL 16oz LIF |
(4) | BLADE SURGICAL# 20 STAINLESS STEEL (1) UTILITY BOWL QUART 32oz LIF |
- Lot codes and dates
- Code 900-2903, 4 lots 113026303 113057705 113068034 113088858
- Amount recalled
- 4 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.
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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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