—#129557

Product

Chole Cystectomy All Endo System , code 900-3025, contains: (1) TABLE COVER 44X 90 UF (1) SYRINGE 20ccW/O NDL LUER LOCK LIF (2) MAYO STAND COVER REINFORCED UF (1) NEEDLE HYPODERMIC (6) ABSORBENT TOWEL 15 X 20 UF (1) NEEDLE HYPODERMIC 22G X 1Y. UF (4) UTILITY DRAPE WIT APE UF (1) TROCAR DILATING XCELL 5MM X 100 (3) GOWN XL SURGICAL MICROCOOL L/F (1) TROCAR ENDOPATH XCEL DILATING TIP (1) WRAPPER 24" X 24" UF (1) TUBING INSUFFLATING OPEN TIP W/0 VENT UF (1) DRAPE LAP ABDO. W/POUCH 102 X 122 X 78 STD UF (5) APPLICATOR COTTON 6 WOOD UF (1) ULTRA VERES NEEDLE 120MM LIF (1) APPLIER MUL Tl CLIP W/SHAF GUN (1) SPECIMEN CONTAINER 4oz. W/LID & LABEL UF (2) DRAPE :Y. ECONOMY 53" X 77" UF (2) UTLITY BOWL 16oz. UF (1) SCALPEL WEIGHTED SAFETY #11 UF (1) RING BASIN (1) TIME OUT BEACON NON WOVEN UF (1) TUBE SUCTION CONNECT (1) MERLING SKIN PREP APPLIC 39ML UF (1 0) GAUZE SPONGE 4 X 4 16PL Y XRD LIF (2) TOWEL CLOTH HUCK (BLUE) UF (1 0) GAUZE SPONGE 4 X 4 16PL Y UF (1) SCISSOR CURVED W/MONOPOLAR CAUTERY 5MM (5) LAP SPONGE PRE-WASH 18" X 18" XRD UF (1) DISSECTOR CURVED W/MONOPLAR CAUTERY 5MM (1) SKIN MARKER INK W/8 LABEUTIMEOUT/RULER LIF (2) LIGHT SHIELD UF (1) SUTURE BAG FLORAL UF (4) DRESSING ISLAND 4 X 6 (1) DRAPE LASER CAMERA W/ELASTIC 6X 96 (1) PK. STERI STRIP CLOSURE (1) NEEDLE & BLADE COUNT 60C FOAM STR/MAG STR UF (1) MAYO TRAY SMALL (1) SYRINGE 30ML SLIP TIP 1 ML UF Product Usage: 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: Code 900-3025, 1 lot: 131110114

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 #129557. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.