FDA Enforcement Class I Terminated

LAPAROSCOPY CHOLECYSTECTOMY PACK- (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD UF (2) ABSORBENT TOWELS 15" X 20" UF (1) MAYO STAND COVER REINFORCED UF (4) BANDAGE ADHESIVE W' x 3" L I F (4) DRAPE UTILITY WIT APE UF (1) TUBE SUCTION CONNECT. Y..'' X 12' UF (1) INSUFLAT TUBING SET W/0 RING ADAPTOR UF (1) LAPAROSCOPY ABO. DRAPE W/Pouch UF (1) IMP. GOWN REINFORCED XLge. SMS (2) SYRINGE 60ML W/0 NDL. LILOCK UF (1) SYRNGE 20 cc W/0 NDL ULOCK UF (1) SURGICAL BLADE #15 C/STEEL (1) DRAPE LASER CAMERA W/EL (2) COVER HANDLE LITE LOCK (1) TABLE COVER Reinforced 50" x 90" UF (3) DRAPE SHEET 41 " x 58" SMS (1) SURG. GOWN REINFORCED T/Wrap Lge. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Recall: Z-2399-2014 · Reported September 10, 2014

Enforcement

Recall Number: Z-2399-2014
Event ID: 68536
Classification: Class I
Status: Terminated
Product Type: Devices
Firm: Customed, Inc
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Letter
Report Date: September 10, 2014
Initiation Date: May 20, 2014
Classification Date: August 29, 2014
Termination Date: August 14, 2017
Address: Calle Igualdad Final #7, Fajardo, PR, 00738, United States

Description

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.

Code Info

Product code 900-1515, 2 lots: 110061486 111030825

Distribution

Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.

Quantity

2 lots; 148 units (multiple units per lot)