Recall Z-2323-2014— 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: LAPAROSCOPY CHOLE PACK - - ( 1) STRIP STERI CLOSURE W' X 4" LIF ( 1) TABLE COVER REINFORCED 50" X 90" LIF ( 1) DRAPE LAP ABDOMINAL W/POUCH 102" X 122" X 78" LIF (2) GOWN LGE SMS IMPERVIOUS REINFORCED LIF ( 1) GOWN XL SMS IMPERVIOUS REINFORCED L/F (5) TOWELS ABSORBENT 15" X 20" LIF (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (4) DRAPE UTILITY WIT APE LIF ( 1) COVER CAMERA W/ELAST LIF (2) GAUZE SPONGE 4" X 4" 12PL Y LIF ( 1) NEEDLE ULTRA VERES 120mm LIF (2) DRAPE SHEET 41 " X 58" SMS LIF ( 1) SCALPEL WEIGHTED SAFETY #11 ( 1) TUBING INSUFFLATING OPEN TIP W/0 VENT LIF ( 1) DRESSING TEGADERM 4" X 4 %" LIF ( 1) TUBE SUCTION CONNECT X" X 12' LIF ( 1) MAYO STAND COVER REINFORCED LIF ( 1) SUTURE BAG FLORAL LIF ( 1) Pk. STERI STRIP LAP SET LATEX ( 1) CORD LAPAROSCOPY MONOPOLAR LIF ( 1) MAYO TRAY SMALL LIF ( 1) TIME OUT BEACON NON WOVEN ST. LIF (1) SKIN MARKER INK W/8 LABEL TIME OUT/RULER LIF ( 1) BAG ZIP LOCK PLASTIC 6" X 10" 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 different 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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