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Customed, Inc

699 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
VAGINAL PROCEDURE PACK CUSTOM ED CONTENTS: (1) DRAPE LITHOTOMY 110" X 63" W/LEGGINGS I POU recall (Z-2453-2014)Customed, Inc2014-08-29
TOTAL HYCTERECTOMY (I) CANNULA 5MM XCEL SLEEVES LIF ( I ) TROCAR XCEL BLADELESS II MM (I) recall (Z-2454-2014)Customed, Inc2014-08-29
EAR PACK CONTENTS: (I) CAUTERY PENC IL ROCKER SW I TI-I CH ( I ) EMESIS BASIN l Oin 700cc recall (Z-2455-2014)Customed, Inc2014-08-29
EXTREMITY ARM PACK CONTENTS: (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) GOBAN SELF-ADHERENT recall (Z-2456-2014)Customed, Inc2014-08-29
CENTRAL LINE DRAPE PACK 1) MASK PROCEDUAL EAR LOOP 120MM HG V/B L/Free (1) DRAPE SHEET 41" recall (Z-2457-2014)Customed, Inc2014-08-29
KNEE ARTHROSCOPY PACK 4 CUSTOMED CONTENTS: (1) COVER TABLE REINFORCED 50" X 90" (1) GOWN S recall (Z-2458-2014)Customed, Inc2014-08-29
08 PAD PACK II (2,3) CUSTOMED CONTENTS: (3) TOWEL ABSORBENT 15" X 20" (1) BOWL W/LID PLAST recall (Z-2459-2014)Customed, Inc2014-08-29
BASIC PACK IV (6) CUSTOMED CONTENTS: (3) TOWELS ABSORBENT 15" X 20" (1) MAYO STAN COVER RE recall (Z-2460-2014)Customed, Inc2014-08-29
BASIC PACK 1 (Ill) CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 44" X 78" (4) DRAPE UTILI recall (Z-2461-2014)Customed, Inc2014-08-29
ARTHROSCOPY PACK I (1) CUSTOMED CONTENTS: (1) TOWELS ABSORBENT 15" X 20" (1) GOWN XL SMS I recall (Z-2462-2014)Customed, Inc2014-08-29
C - BIRTH PACK II {2) CUSTOMED CONTENT: (1) GOWN SURGEON REINFORCED XLGE TOWEL/WRAP LIF (4 recall (Z-2463-2014)Customed, Inc2014-08-29
MINOR EXTREMITY PACK {2) CUSTOMED CONTENT: (1) GOWN LGE STD SMS VELC/NE T/WRAP (1) TOWELS recall (Z-2464-2014)Customed, Inc2014-08-29
CYSTOSCOPY PACK Ill (1) (2) CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 44" X 78" (2) TO recall (Z-2465-2014)Customed, Inc2014-08-29
LAPAROSCOPY ABO PACK (1) (2) CUSTOMED CONTENTS: (1) GOWN SURG. REINFORCED X-LARGE TOWEL I recall (Z-2466-2014)Customed, Inc2014-08-29
LAPAROSCOPY PACK I (4) CUSTOMED CONTENTS: (1) TOWEL ABSORBENT 15" X 20" LIF (2) LEGGINGS W recall (Z-2467-2014)Customed, Inc2014-08-29
LAPAROTOMY PACK 1 (2&3) CUSTOMED CONTENT: (2) TOWEL ABSORBENT 15" X 20" (1) MAYO STAND COV recall (Z-2468-2014)Customed, Inc2014-08-29
TRANSVERSE LAPAROTOMY PACK (8) CUSTOMED CONTENT: (1) TOWEL ABSORBENT 15" X 20" (1) MAYO ST recall (Z-2469-2014)Customed, Inc2014-08-29
LAPAROTOMY PACK Ill (4) CUSTOMED CONTENT: (4) TOWEL ABSORBENT 15" X 20" (2) GOWN XLARGE SM recall (Z-2470-2014)Customed, Inc2014-08-29
EENT PACK I CUSTOMED CONTENT: (2) TOWEL ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCE recall (Z-2471-2014)Customed, Inc2014-08-29
ORTHOPEDIC PACK I (2) CUSTOMED, 900-2503, contains: (2) TOWELS ABSORBENT 15" X 20" LIF (1) recall (Z-2472-2014)Customed, Inc2014-08-29
ORTHOPEDIC PACK Ill (1) CUSTOMED CONTENTS: (1) GOWN XL SMS IMPERVIOUS REINFORCED (4) DRAPE recall (Z-2473-2014)Customed, Inc2014-08-29
Urology Pack, 900-2510, package contains: (2) TOWELS ABSORBENT 15X 20 UF (1) DRAPE LITHO 1 recall (Z-2474-2014)Customed, Inc2014-08-29
Minor Pack 900-2511, pack contains: (1) GOWN XLGE SMS IMPERVIOUS REINFORCED AAMIIII (10) G recall (Z-2475-2014)Customed, Inc2014-08-29
Laparotomy Pack, 900-2516, pack contains: ( I) TABLE COVER44" X 90" ( I) CAUTERY PENCIL PU recall (Z-2476-2014)Customed, Inc2014-08-29
Gown Cool Impervious XLGE Breathable Customed, 900-2592: (1) GOWN XL SURGICAL MICROCOOL (1 recall (Z-2477-2014)Customed, Inc2014-08-29
Arthroscopy Pack,900-2609, contains: (5) LAP SPONGE PREWASH 18" X 18" XRD (1) SHEET ARTHRO recall (Z-2478-2014)Customed, Inc2014-08-29
Hip & Knee replacement pack, 900-2614, contains (1) CAUTERY TIP POLISHER UF (1) BAG SUTURE recall (Z-2479-2014)Customed, Inc2014-08-29
Extremity Pack, code 900-2615, contains: (5) LAP SPONGE PREWASH 18" X 18" XRD (1) ELASTIC recall (Z-2480-2014)Customed, Inc2014-08-29
Shoulder Pack, Code 900-2616, contains: (2) TUBE SUCTION CONNECT Y."X12' UF (1) SYRINGE 20 recall (Z-2481-2014)Customed, Inc2014-08-29
Open Heart Pack, code 900-2618, contains: (9) DRAPE 60" X 76" REINFORCED LIF ( 1) MAYO STA recall (Z-2482-2014)Customed, Inc2014-08-29
LAP Abdom w/pouch Customed code 900-2619, contains: (1) DRAPE LAP. ABDOM W/POUCH 102" X 12 recall (Z-2483-2014)Customed, Inc2014-08-29
HIP PACK I (2), CUSTOMED, code 900-2504 (1) GOWN SURG. REINFORCED XLGE TOWEL/WRAP (1) MAYO recall (Z-2484-2014)Customed, Inc2014-08-29
Universal Pack II (2) Customed 900-2509 (1) MAYO STAND COVER REINFORCED (2) DRAPE SIDE 42" recall (Z-2485-2014)Customed, Inc2014-08-29
Shoulder pack (I) (2), code 900-2515 (1) GOWN IMP. XTRA REINF. XL TOWEL WRAP LEVEL Ill (1) recall (Z-2486-2014)Customed, Inc2014-08-29
Plastic Pack Customed, code 900-2582 (1) GOWN LGE SMS IMP REINF L/F (1) GOWN SURG. REINF L recall (Z-2487-2014)Customed, Inc2014-08-29
Face Pack MRT, product code 900-2654, contains: (2) GOWN SOFT SMS STD X-LARGE SET IN SLEEV recall (Z-2488-2014)Customed, Inc2014-08-29
Liposuction Pack MRT, code 900-2656, contains: (1) NEEDLE HYPODERMIC 27 X 1 LIF (1) UTILIT recall (Z-2489-2014)Customed, Inc2014-08-29
Tummy Pack MRT, code 900-2657, contains: (2) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAU recall (Z-2490-2014)Customed, Inc2014-08-29
Breast Pack MRT, code 900-2658, contains: ( 1) BULB SYRINGE 60cc (2) GOWN SOFT SMS STD XLG recall (Z-2491-2014)Customed, Inc2014-08-29
Breast Implant Pack, Code 900-2660, contains: (1) DRAPE ECONOMY 53 X 77 (3) GOWN SOFT SMS recall (Z-2492-2014)Customed, Inc2014-08-29
Tummy Tuck and Liposuction Pack, code 900-2661, contains: ( 1) DRAPE % ECONOMY 53 X 77 (3) recall (Z-2493-2014)Customed, Inc2014-08-29
Liposuction Pack, code 900-2681, contains: (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE (1) TU recall (Z-2494-2014)Customed, Inc2014-08-29
Breast Augmentation Pack, Imagenes Cosmetic, code 900-2682: (3) GOWN SOFT SMS STD XLGE SET recall (Z-2495-2014)Customed, Inc2014-08-29
Tummy Tuck Pack, code 900-2684, contains: (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CA recall (Z-2496-2014)Customed, Inc2014-08-29
Bandeja para Debridacion, code 900-2702, contains: (1) FORCEP ADSON TISS (20) GAUZE SPONGE recall (Z-2497-2014)Customed, Inc2014-08-29
Endovascular Pack, code 900-2715, contains: ( I) DRAPE FEMORAL ANG. 125 X 75 X 56 WITH POU recall (Z-2498-2014)Customed, Inc2014-08-29
Knee Arthroscopy Pack, code 900-2718, contains: (1 0) GAUZE SPONGES 4 X 4 12PL Y (2) PADDI recall (Z-2499-2014)Customed, Inc2014-08-29
Shoulder Arthroscopy Pack, code 900-2719, contains: (1 0) GAUZE SPONGES 4 X 4 12PL Y (1) C recall (Z-2500-2014)Customed, Inc2014-08-29
Gown Surgical Soft SMS Non Reinforced, code 900-2725, contains: (1) GOWN SOFT SMS STD X-LA recall (Z-2501-2014)Customed, Inc2014-08-29
REEMPLAZO DE RODILLA Y CADERA CONTENTS: (6) TOWELS ABSORBENT 15" X 20" (I) PK. STRIP STERI recall (Z-2502-2014)Customed, Inc2014-08-29
MINOR PACK CONTENTS: (1) TOWELS ABSORBENT 15" X 20" (1) WRAPPER 24" X 24" (16) GAUZE SPONG recall (Z-2503-2014)Customed, Inc2014-08-29
NEURO SPINE PACK , CODE 900-2765 CONTENTS: (l ) DRAPE INCISION 23" X 1 7" (I) SCALPEL W/HA recall (Z-2504-2014)Customed, Inc2014-08-29
SHOULDER PACK CODE 900-2766 CONTENTS: (1) STAPLE SKIN 35 WIDE LIF (1) *GOBAN SELF-ADH 4" X recall (Z-2505-2014)Customed, Inc2014-08-29
LAPAROTOMY PACK BASIC CODE 900-2829 CONTENTS: (2) TOWELS ABSORBENT 15" X 20" (1) COVER MAY recall (Z-2506-2014)Customed, Inc2014-08-29
ORTHOPEDIC PACK BASIC CODE 900-2830. CONTENTS: (3) TOWELS ABSORBENT 15" X 20" (1) COVER MA recall (Z-2507-2014)Customed, Inc2014-08-29
CYSTO TUR PACK BASIC CODE 900-2899. CONTENTS: (2) LEGGINGS W/7'' CUFF 30" X 42" (1) COVER recall (Z-2508-2014)Customed, Inc2014-08-29
ORTHOPEDIC IMPLANT PACK CUSTOMED USA, CODE 900-2903 CONTENTS: (1) CAUTERY TIP POLISHER UF recall (Z-2509-2014)Customed, Inc2014-08-29
BASIC COSMETIC SURG. PACK CUSTOMED (USA), CODE 900-2915. CONTENTS: (2) TOWELS ABSORBENT 15 recall (Z-2510-2014)Customed, Inc2014-08-29
ACDFPACK SURGICAL CENTER, CODE 900-2917. CONTENTS: (1) SOLUTION SURGICAL DURAPREP 6ML LIF recall (Z-2511-2014)Customed, Inc2014-08-29
TLIF PACK SURGICAL CENTER, CODE 900-2918. CONTENTS: (2) SOLUTION SURGICAL DURAPREP 26ML UF recall (Z-2512-2014)Customed, Inc2014-08-29
Obstetrical Surgical pack, code 900-2940, contains: (1) BLANKET RECEIVING 100 COTTON (3) T recall (Z-2513-2014)Customed, Inc2014-08-29
Drape Sheet, Product Code 2942, contains (1) DRAPE % ECONOMY 53 X 77L/F (1) WRAPPER 24 X 2 recall (Z-2514-2014)Customed, Inc2014-08-29
Hair Restoration Pack- , code 900-2966, contains: (1) MAYO STAND COVER 23X54 (2) TOWEL CLO recall (Z-2515-2014)Customed, Inc2014-08-29
Basic Pack FPSC Florham Pack , code 900-2969, contains: (1) COVER TABLE REINFORCED 50" X 9 recall (Z-2516-2014)Customed, Inc2014-08-29
Chole Cystectomy All Endo System , code 900-3025, contains: (1) TABLE COVER 44X 90 UF (1) recall (Z-2517-2014)Customed, Inc2014-08-29
Tummy Tuck Pack-BOD , code 900-3026, contains: (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED recall (Z-2518-2014)Customed, Inc2014-08-29
Face Pack- BOD, code 900-3027, contains: (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill (2 recall (Z-2519-2014)Customed, Inc2014-08-29
Liposuction Pack BOD, code 900-3028, contains: (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI recall (Z-2520-2014)Customed, Inc2014-08-29
Breast Pack BOD, code 900-3029, contains: (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMI recall (Z-2521-2014)Customed, Inc2014-08-29
Face Lift , Code 900-3083, contains: (I) SHEET ENT SPLIT 110" X 77" LIF (I) COVER TABLE RE recall (Z-2522-2014)Customed, Inc2014-08-29
General Cosmetic Pack FCSC, Code 900-3113, contains: (1) COVER MAYO STAND REINFORCED LIF ( recall (Z-2523-2014)Customed, Inc2014-08-29
Tummy Tuck Pack- FJG, code 900-3114, contains: (2) GOWN LARGE SMS IMPERVIOUS REINFORCED AA recall (Z-2524-2014)Customed, Inc2014-08-29
Liposuction Pack FJG, code 900-3115, contains: (2) GOWN LARGE SMS IMPERVIOUS REINFORCED AA recall (Z-2525-2014)Customed, Inc2014-08-29
Face Pack FJG, code 900-3116, contains: (2) GOWN LARGE STANDARD SMS AAMIIII (2) TOWEL ABSO recall (Z-2526-2014)Customed, Inc2014-08-29
Breast Pack- FJG, code 900-3118, contains: (2) GOWN LARGE STANDARD SMS AAMIIII (2) TOWEL A recall (Z-2527-2014)Customed, Inc2014-08-29
Laparoscopy pack, , Code 900-3178, contains: (1) BULB SYRINGE 60cc LIF (10) GAUZE SPONGE 4 recall (Z-2528-2014)Customed, Inc2014-08-29
Gown Impervious , Code 900-3190, contains: GOWN IMPERVIOUS EXTRA LONG X-LARGE WITH TOWEL & recall (Z-2529-2014)Customed, Inc2014-08-29
Breast pack TPSC, code 900-3431, contains: (1) GOWN LARGE STANDARD SMS AAMIIII (1) GOWN SO recall (Z-2530-2014)Customed, Inc2014-08-29
Open Heart Tray, Pack A, code 900-1196C, contains: (1) TABLE COVER REINFORCED L/Free (1) C recall (Z-2531-2014)Customed, Inc2014-08-29
Cirugia Cardiovascular Case Cart, c ode 900-1415A, contains: (1) CIRUGIA CARDIOVASCULAR .( recall (Z-2532-2014)Customed, Inc2014-08-29
LAPAROSCOPY COLORECTAL SURGICAL PACK code 900-2259A, contains: (1) SOLUTION SURGICAL DURAP recall (Z-2533-2014)Customed, Inc2014-08-29
Lithotomy Pack III (3), code 900-2487, contains: (3) TOWEL ABSORBENT 15" X 20" (1) GOWN LA recall (Z-2534-2014)Customed, Inc2014-08-29
Suture removal kit, catalog# 900-010 recall (Z-1251-2012)Customed, Inc2012-03-21
Irrigation Tray w/Bulb syringe, catalog# 900-020 recall (Z-1252-2012)Customed, Inc2012-03-21
Prep shave kit, catalog# 900-030 recall (Z-1253-2012)Customed, Inc2012-03-21
Universal drainage kit, catalog# 900-032 recall (Z-1254-2012)Customed, Inc2012-03-21
Tracheotomy care kit, catalog# 900-110 recall (Z-1255-2012)Customed, Inc2012-03-21
Suction Catheter Kit, catalog# 900-277 recall (Z-1256-2012)Customed, Inc2012-03-21
Urethral Catheter Tray catalog# 900-278 recall (Z-1257-2012)Customed, Inc2012-03-21
Incision and Drainage Tray, catalog# 900-774 recall (Z-1258-2012)Customed, Inc2012-03-21
Skin Stapler Removal Kit , catalog# 900-782 recall (Z-1259-2012)Customed, Inc2012-03-21
Minor laceration tray , catalog# 900-1765 recall (Z-1260-2012)Customed, Inc2012-03-21
Wound Closure Tray I, catalog# 900-063 recall (Z-1261-2012)Customed, Inc2012-03-21
Wound Closure Tray II, catalog# 900-064 recall (Z-1262-2012)Customed, Inc2012-03-21
Wound Management Tray, catalog# 900-540 recall (Z-1263-2012)Customed, Inc2012-03-21
Wound Management Tray Asoc. Agencia Salud, catalog# 900-1154 recall (Z-1264-2012)Customed, Inc2012-03-21
Wound Management Tray, catalog# 900-1456 recall (Z-1265-2012)Customed, Inc2012-03-21
Wound Management Ryder, catalog# 900-1605 recall (Z-1266-2012)Customed, Inc2012-03-21
Wound Management Tray Aten cion med. EN El Hogar, catalog# 900-1903 recall (Z-1267-2012)Customed, Inc2012-03-21
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