—#129287

Product

REYITO UROLOGY PACK - (2) GOWN IMP. REINFORCED X-LARGE SMS (2) TOWELS ABSORBENT UF ( I) URINARY DRAIN. BAG 2000ML ANTI-REFLUX UF ( I) SYRINGE 30cc W/0 NDL. LUER LOCK UF ( I) BAG SUTURE (I) TABLE COVER ( I} TUBE SUCTION CONNECT. W' X 12' UF (10) GAUZE SPONGES 4" X 4" 16PLY ( I) EMESIS BASIN (I) DRAPE LASER CAMERA W/E ( I} UTILITY BOWL32oz (I) BOWL PLASTIC 80oz WITH LID ( I) SYRINGE IOcc W/0 NDL. LUER LOCK UF (I} SYRINGE IOcc PREFILLED WITH GEL (5) CONTAINER SPECIMEN 4oz W/LID & LABEL (I) GOWN SURG. REINFORCEDT/WRAP X-LARGE ( I} TUR Y SET, 2LEAD UF ( I} DRAPE LITHO 11 0" X 63" WI POUCH WILEGGING ( I} ROUND WASH BASIN 6QT. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: Product code 900-1460, 29 lots: 109050945 111123344 112010046 112020337 112041074 112051759 112062229 112062272 112083031 112083391 112093722 112114564 112124948 113015428 113036592 113047001 113047147 113057686 113067887 113078253 113078702 113089190 131110174 131210632 140111081 140211866 140311920 140312391 140513089

Why it was recalled

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.

Root cause (FDA determination)

Package design/selection

Action the firm took

Customed Inc. sent a Recall Notification letter dated June 3, 2014 via email and followed by letter to all affected customers. The letter identified the affected products, problem and actions to be taken. The letter informed customers if the affected products are in their inventory to: 1. Remove products from sale (quarantine them) and cease distribution. 2. Complete and return the enclosed acknowledgement form to Customed Inc .Recall Coordinator. Affected products should be returned to Customed Inc for credit. Customers with questions were instructed to contact Customed Inc. Recall Coordinator at 1-787-801-0100 Ext. 7540

Recalling firm

Firm: Customed, Inc Calle Igualdad Final # 7
Address: Fajardo, Puerto Rico 00738

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2014-05-20
Posted by FDA: 2014-08-29
Terminated: 2017-08-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #129287. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.