Recall Z-2432-2014— Customed, Inc

Class I FDA medical device recall by Customed, Inc, initiated 2014-05-20, terminated 2017-08-14. FDA's recall record names no specific 510(k) clearance for this event. Product: ORTHOPEDIC SURGICAL PACK HOSPITAL SAN CRISTOBAL CONTENTS: (I) CAUTERY TIP POLISH ER LIF (1) BAG SUTURE FLORAL (1) TUBE SUCTION CONNECT W' X 1 2' LIF (1) BAG GLASSINE (2) LITE GLOVE (1) TABLE COVER BTC 77" X 11 0" HD FULL COVERAGE LIF (1) MAYO STAND COVER REINFORCED LIF (5) TOWELS ABSORBENT 1 5" X 20" LIF (4) DRAPE UTILITY WITH TAPE LIF ( 1 ) DRAPE SHEET 70" X 100" L/ F (5) LAP SPONGE PREWASH 18" X 1 8" XRD LIF (1 ) MAYOTRAYLARGE (1) DRAPE TOP WITH ADHESIVE 108" X 50" STD SMS LIF (1) SKIN STAPLER WIDE 35 LIF ( 1) DRAPE INCISE ANTI M I CROBIAL 23" X 1 7" LIF (1) SKIN MARKER WITH RULER (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" X 2 1 " LIF (1 ) PAD ABDOM INAL 8" X 7"h.'' (1) YAUNKAUER SUCTION TUBE WITHOUT VENT LIF (1) SOLUTI ON SURG ICAL DURAPREP 26ML LIF (1 ) BLADE SURG ICAL #10 STAINLESS STEEL (I) SPLIT SHEET WITH ADHESIVE 108" X 77" STD SMS LIF (2) *Prs. GLOVE # 8.5 SURGEON NEUTRALON LATEX ( I ) *Pr. GLOVE# 8 SURGEON NEUTRALON LATEX ( I ) GOWN SURG. REINFORCED XL TOWEL/WRAP AAMI Ill (3) GOWN XL SMS IM PERVIOUS REINFORCED AAM I III LIF ( I ) CAUTERY PENCIL ROCK ER SWITCH (2) *Prs. GLOVES SURG. # 8 POWDER (4) Prs. GLOVES SURG. 8.5 Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.. Reason: Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition..

Recalling firm

Customed, Inc

Classification

Class I

Status

Terminated

Initiated

2014-05-20

Terminated

2017-08-14

Firm location

Fajardo, PR, United States

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