Reported Sep 10, 2014 · Terminated
Hip & Knee replacement pack, 900-2614, contains (1) CAUTERY TIP POLISHER UF (1) BAG SUTURE FLORAL (1) TUBE SUCTION…
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?
- Hip & Knee replacement pack, 900-2614, contains (1) CAUTERY TIP POLISHER UF (1) BAG SUTURE FLORAL (1) TUBE SUCTION CONNECT Y." X 12' UF (1) TABLE COVER REINFORCED 50" X 90" UF (1) MAYO STAND COVER REINFORCED UF (5) TOWELS ABSORBENT 15" X 20" UF (2) DRAPE SHEET 70" X 100" L/F (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) SKIN STAPLE 35 WIDE LIF (1) MAYO TRAY LARGE (1) TOP DRAPE WITH ADHESIVE 100" X 50" SMS STD L/F (1) BULB SYRINGE 60cc (1) UTILITY BOWL 16oz (1) UTILITY BOWL QUART 32oz (1) INCISION DRAPE 23" X 17" (1) SKIN MARKER WITH RULER (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6 X 21 (1) YANKAUER SUCTION TUBE WITHOUT VENT UF (1) MERLING SKIN PREP APPLIC. 39ML UF (1) BLADE SURGICAL# 10 STAINLESS STEEL (1) SHEET SPLIT WITH ADHESIVE 108" X 77" UF (1) *GLOVE# 7.5 SURGEON NEUTRALON LATEX (1) * GLOVE # 8 SURGEON NEUTRALON LATEX (1) *GLOVE# 8.5 SURGEON NEUTRALON LATEX (3) GOWN IMPERVIOUS EXTRA REINFORCED XL LIF (1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL & WRAP (4) UTILITY DRAPE WITH TAPE UF (1 0) GAUZE SPONGE 4" X4" 16PL Y XRD LIF (2) BANDAGE ELASTIC WITH VELCRO 6" X 5yds (1) BLADE SURGICAL# 20 STAINLESS STEEL (2) LITE GLOVE UF (1) STOCKINETIE IMPERVIOUS 12" X 48" (1) CAUTERY PENCIL ROCKER SWITCH UF (1) BANDAGE ESMARK 6"
- X 9yds UF Product UsageEO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
- Lot codes and dates
Product code 900-26141
- lot140312137
- Amount recalled
- 1 lot (30 packed units)
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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