—#129272

Product

LAPAROSCOPY OB GYN PACK - (1) DURAPREP SURGICAL SOLUTION 26ML LIF (1) SHEET T LAPAROSCOPY SMS LIF (2) DRAPE UTILITY WITH TAPE LIF (1) DRAPE SHEET 41" X 58" SMS LIF (4) ABSORBENT TOWELS 15" x 20" LIF (1) PVP TRIPLE SWABSTICK IODOPHOR (1) DRAPE LASER CAMERA W/EL 6" X 96" (1) TUBE SUCTION CONNECT.%" X 12' LIF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF (1) SURGICAL BLADE #11 CARBON STEEL (1) TABLE COVER 44" X 78" REINFORCED LIF (1) TEGADERM TRANS DRESSING 6" X 8" (2) LEGGINS WITH 7" CUFF 30" X 42" (10) GAUZE SPONGES 4" X 4" 12PLY XRD (1) BAG URINARY DRAINAGE 2000ML ANTI-REFLUX (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR LIF (1) TUR CYSTO IRRIGATION SET 79" (1) FOLEY CATHETER 16FR 2WAY, 5CC (2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF (2) GOWN IMPERVIOUS EXTRA REINF XLG LIF (1) TROCAR ENDO. XCEL DILATING TIP 5MM (K5LT) (1) PNEUMO INSUFLAT NEEDLE 150MM LUER LOCK LIF (1) CEFAZOLIN RED LABEL (1) GENTAMICIN GREEN LABEL (1) AZUL DE METILENO LABEL (1) HEPARINE WHITE LABEL (1) LIDOCAINE YELLOW LABEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

FDA product code: OHD — Gynecological Laparoscopic Kit
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
Affected lot / code info: Product code 900-1192, 10 lots: 113057752 113067947 113078458 113078680 113099381 140211710 140312054 140412584 140513072 140513334

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 #129272. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.