—#129245

Product

GENERAL MINOR PACK- (1) MAYO STAND COVER REINFORCED LIF (2) BOWL UTILITY 16oz LIF (1) TIP CAUTERY POLISHER LIF (3) TOWELS ABSORBENT 15" X 20" LIF (1) BOWL UTILITY 32oz (1) BAG SUTURE FLORAL (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (10) GAUZE SPONGES 4" X 4" 16PLY XRD LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (2) GOWN IMPERVIOUS REINFORCED LARGE SMS LIF (1) CAUTERY PENCIL ROCKER SWITCH LIF (1) BLADE SURGICAL #10 STAINLESS STEEL (1) TUBE SUCTION CO NNECTING ~" X 12' LIF (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (2) LITE GLOVES LIF (1) DRAPE LAPAROTOMY WITH POUCH 102" X 121" X 78" STD SMS (4) DRAPE UTILITY WITH TAPE LIF (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) BLADE SURGICAL #15 CARBON STEEL (2) SHEET DRAPE 41" X 69" MEDIUM LIF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF 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 900-787, 25 lots: 109010128 112030747 112052015 112062577 112093733 112114397 112114483 112125114 113015516 113025969 113036383 113047206 113057819 113068181 113078606 113099296 113099577 131110278 131110606 131210973 140111454 140211879 140312331 140412842 140513251

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 #129245. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.