—#129179

Product

LAPAROSCOPY~OBPACK - (4) ABSORBENT TOWELS 15" x 20" LIF (2) LEGGINS WITH 7" CUFF (1) LAPAROSCOPY T SHEET SMS (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) NEEDLE HYPODERMIC 18G X 1% (1) *ROBIN REDRUBBER CATHETER 14FR LATEX (1) DRAPE LASER CAMERA W/EL LIF (1) PAD OBSTETRICAL X-LARGE 6" X 96" LIF (3) TOWEL CLAMP (4) DRAPE UTILITY WITH TAPE LIF (1) GOWN SURGICAL POLY REINFORCED BREATHABLE IMP LARGE LEVEL IV (2) GOWN SURG POLY REINFORCED BREATHABLE IMP XL SMS LEVEL IV (20) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) TABLE COVER 44" X 90" (1) MAYO STAND COVER REINFORCED LIF (1) SURGICAL BLADE #15 CARBON STEEL (1) LITE GLOVE LIF (1) DRESSING NON-ADHESIVE TELFA 4" X 3" (1) TUBE SUCTION CONNECT Y4" X 12' LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents

FDA product code: FDE — Laparoscopy Kit
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: Product code 900-484, 25 lots: 110112811 110123129 111010130 111030679 111040976 111051201 111071818 111082100 111092392 111092547 111123258 112020476 112041331 112072873 112083432 112093945 113026060 113026073 113036489 113036802 113067928 113088868 113109845 131210819 140211845

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 #129179. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.