FDA Enforcement Class I Terminated

PREMIUM UROLOGY PACK - CUSTOMED- (1) LITHOTOMY DRAPE W/POUCH ANESTH. (2) ABSORBENT TOWELS UF (1) MAYO STAND COVER REINFORCED UF (1) URINARY DRAINAGE BAG 2000ml ANTI-REFLUX UF (1) GOWN SURG. REINFORCED LARGE T/WRAP (1) UTILITY BOWL 32 OZ. (1) TUBE SUCTION CONNEC. W' X 12' UF (1) TABLE COVER REINFORCED 50" X 90" UF (1) TUR Y SET 81 "2.1M REGULAR CLAM ST. (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) SPECIMEN CONTAINER 4oz. W/LID & LABEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Recall: Z-2383-2014 · Reported September 10, 2014

Enforcement

Recall Number: Z-2383-2014
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 900-1295, 2 lots: 111030561 112031009

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; 258 units (multiple units per lot)