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3,817 recalls
CriticalFDA
Customed, Inc
HIP PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" (2) GOWN XL SMS IMPERV. REINFORCED (1) MAYO STAND COVER REINFORCED (1) SUTU...
Surgical Devices·4 affected·May 20, 2014
CriticalFDA
Customed, Inc
Minor Pack 900-2511, pack contains: (1) GOWN XLGE SMS IMPERVIOUS REINFORCED AAMIIII (10) GAUZE SPONGE 4" X 4" 16PLY XRD (5) LAP SPONG...
Surgical Devices·10 affected·May 20, 2014
CriticalFDA
Customed, Inc
BASIC PACK W/OUT GOWN- (1) TABLE COVER REINFORCED 50" X 90" UF (4) DRAPE UTILITY WITH TAPE UF (1) TOWEL ABSORBENT 15" x 20" L/F (1) S...
Surgical Devices·38 affected·May 20, 2014
CriticalFDA
Customed, Inc
Customed Laparoscopy convenience pack include multiple components: gowns, table covers, needle and blade counter, bag suture, suture, sp...
Surgical Devices·30 affected·May 20, 2014
CriticalFDA
Customed, Inc
EAR PACK CONTENTS: (I) CAUTERY PENC IL ROCKER SW I TI-I CH ( I ) EMESIS BASIN l Oin 700cc (2) LABEL FOR SKIN MARKERS ( I) ...
Surgical Devices·3 affected·May 20, 2014
CriticalFDA
Customed, Inc
CESAREAN PACK- (1) COVER TABLE REINFORCED 50" X 90" (2) TOWELS ABSORBENT 15" X 20" (1) BABY BLANKET PRINTED (1) BOWL PLASTIC WITH LI...
Surgical Devices·16 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAPAROSCOPY PACK I (4) CUSTOMED CONTENTS: (1) TOWEL ABSORBENT 15" X 20" LIF (2) LEGGINGS W/7'' CUFF 30" X 42" LIF (1) DRAPE UTILITY W...
Surgical Devices·2 affected·May 20, 2014
CriticalFDA
Customed, Inc
PERY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" (1) DRAPE UTILITY (2) TOWELS ABSORBENT 15" X 20" (1) GOWN XL SMS IMPERV. REI...
Surgical Devices·2 affected·May 20, 2014
CriticalFDA
Customed, Inc
CENTRAL LINE DRAPE PACK 1) MASK PROCEDUAL EAR LOOP 120MM HG V/B L/Free (1) DRAPE SHEET 41" X 58" SMS L/Free (1) CAP NURSE 21" GRE...
Surgical Devices·6 affected·May 20, 2014
CriticalFDA
Customed, Inc
CESAREAN PACK- - (3) ABSORBENT TOWELS 15" x 20" LIF (1) PLASTIC BOWL WITH LID 80oz. (1 0) LAP SPONGES PRE-WASH 18" x 18" XRD (2) PA...
Surgical Devices·47 affected·May 20, 2014
CriticalFDA
Customed, Inc
CESAREAN PACK - (1) BABY BLANKET IMP. 30" X 30" POLY ABS. (1) NEEDLE & BLADE COUNTER 60c FOAM/STRIP MAG/STRIP LIF (1) DRESSING ISLAND...
Surgical Devices·20 affected·May 20, 2014
CriticalFDA
Customed, Inc
Extremity Pack, code 900-2615, contains: (5) LAP SPONGE PREWASH 18" X 18" XRD (1) ELASTIC BANDAGE WITH VELCRO 4 X 5 (2) BLADE SURGICAL...
Surgical Devices·6 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAPAROTOMY PACK- (1) MAYO STAND COVER REINFORCED LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (5) LAP SPONGES PRE-WASH 18" X 18" XRD...
Surgical Devices·34 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAPAROSCOPY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" (1) LAPAROSCOPY SHEET "T" SMS (3) TOWELS ABSORBENT 15" X 20" (1) SURGIC...
Surgical Devices·24 affected·May 20, 2014
CriticalFDA
Customed, Inc
CESAREAN PACK- (1) BEANNIES BABY LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) COVER MAYO STAND REINFORCED LIF (3) SHEET DRAPE 41...
Surgical Devices·19 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAPAROSCOPY CHOLE PACK - - ( 1) STRIP STERI CLOSURE W' X 4" LIF ( 1) TABLE COVER REINFORCED 50" X 90" LIF ( 1) DRAPE LAP ABDOMINAL W/...
Surgical Devices·26 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAPAROSCOPY OB GYN PACK - (1) DURAPREP SURGICAL SOLUTION 26ML LIF (1) SHEET T LAPAROSCOPY SMS LIF (2) DRAPE UTILITY WITH TAPE LIF (1...
Surgical Devices·10 affected·May 20, 2014
CriticalFDA
Customed, Inc
Tummy Tuck Pack, code 900-2684, contains: (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM ( 1) TUBE SUCTION C...
Surgical Devices·2 affected·May 20, 2014
CriticalFDA
Customed, Inc
CARPALTUNNELLARGE - (1) TABLE COVER 50" X 90" REINFORCED LIF (1) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF (1) UTILITY BOWL 32oz LIF ...
Surgical Devices·38 affected·May 20, 2014
CriticalFDA
Customed, Inc
REEMPLAZO DE RODILLA Y CADERA CONTENTS: (6) TOWELS ABSORBENT 15" X 20" (I) PK. STRIP STERICLOSURE Y," X 4" (I) COVER MAYO STAN...
Surgical Devices·7 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAPAROSCOPY CHOLE PACK - (1) DRAPE LASER CAMERA WITH ELASTIC 6" X 96" LIF (2) SHEET DRAPE 42" X 57" SMS (1) TUBE SUCTION CONNECT. %" ...
Surgical Devices·16 affected·May 20, 2014
CriticalFDA
Customed, Inc
Universal Pack- - (1) TABLE COVER REINFORCED 50" X 90" LIF (3) TOWEL ABSORBENT 15" X 20" LIF (1) MAYO STAND COVER REINFORCED LIF (1...
Surgical Devices·8 affected·May 20, 2014
CriticalFDA
Customed, Inc
Face Pack- BOD, code 900-3027, contains: (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWELS ABSORBENT 15" X 20" (1 ) DRAPE INST...
Surgical Devices·1 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAPAROSCOPY CHOLECYSTECTOMY PACK- (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD UF (2) ABSORBENT TOWELS 15" X 20" UF (1) MAYO STAND COVER REI...
Surgical Devices·2 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAPAROSCOPY CHOLECYSTECTOMY SURGICAL PACK - - (1) DRAPE LAPAROS/ABDOMINAL UF (1) GOWN IMPER. EXTRA REINFORCED LGE TIVVRAP (1) BL...
Surgical Devices·2 affected·May 20, 2014
CriticalFDA
Customed, Inc
Hip & Knee replacement pack, 900-2614, contains (1) CAUTERY TIP POLISHER UF (1) BAG SUTURE FLORAL (1) TUBE SUCTION CONNECT Y." X 12' U...
Surgical Devices·1 affected·May 20, 2014
CriticalFDA
Customed, Inc
UROLOGY PACK- (2) SYRINGE 30ML SLIP TIP 1 ML LIF (2) GOWN SURG. REINFORCED LARGE TOWEL & WRAP (1 0) GAUZE SPONGE 4" X 4" 12 PLY (1) ...
Surgical Devices·36 affected·May 20, 2014
CriticalFDA
Customed, Inc
MINOR LAPAROTOMY PACK - (1) DRAPE T LAPAROTOMY (1) BAG SUTURE FLORAL LIF (4) DRAPE UTILITY WITH TAPE LIF (1) TABLE COVER REINFORCED 5...
Surgical Devices·60 affected·May 20, 2014
CriticalFDA
Customed, Inc
VEIN PACK - (1) GOWN STANDARD LARGE SMS VELCRO/NECK (3) LAP. SPONGES PREWASH XRD LIF (1) EXTREMITY SHEET ABS LIF (1) WRAPPER 36" X 3...
Surgical Devices·3 affected·May 20, 2014
CriticalFDA
Customed, Inc
D & C LAPAROSCOPY PACK - (1) TUBING INSUFFLATION OPEN TIP WITHOUT VENT (1) MAYO STAND COVER REINFORCED UF (4) DRAPE UTILITY UF (1) T...
Surgical Devices·22 affected·May 20, 2014
CriticalFDA
Customed, Inc
MINOR PACK CONTENTS: (1) TOWELS ABSORBENT 15" X 20" (1) WRAPPER 24" X 24" (16) GAUZE SPONGES 2" X 2" 8PLY (1) TRAY HALF SHAL...
Surgical Devices·3 affected·May 20, 2014
CriticalFDA
Customed, Inc
MINOR EXTREMITY PACK {2) CUSTOMED CONTENT: (1) GOWN LGE STD SMS VELC/NE T/WRAP (1) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COV...
Surgical Devices·1 affected·May 20, 2014
CriticalFDA
Customed, Inc
Customed Cysto Tur Pack, convenience pack include multiple components: legging with cuff, drape cystoscopy, towel absorbent & table cover...
Surgical Devices·37 affected·May 20, 2014
CriticalFDA
Customed, Inc
SURGICAL PACK CONTENTS: (1) SUTURE BAG FLORAL (1) WRAPPER 30" X 30" (2) UTILITY BOWL 16oz (1) TRAY ORGANIZER FULL DEEP (1) ...
Surgical Devices·31 affected·May 20, 2014
CriticalFDA
Customed, Inc
ARTHROSCOPY PACK- (1) VIDEO CAMERA DRAPE 13cm X 244cm LIF (2) BANDAGE ELASTIC 6" X 5yrd. LIF (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (...
Surgical Devices·16 affected·May 20, 2014
CriticalFDA
Customed, Inc
ORTHOPEDIC PACK Ill (1) CUSTOMED CONTENTS: (1) GOWN XL SMS IMPERVIOUS REINFORCED (4) DRAPE UTILITY WffAPE (1) MAYO STAND COVER RE...
Surgical Devices·0 affected·May 20, 2014
CriticalFDA
Customed, Inc
CARPAL TUNNEL SURGICAL LARGE PACK (1) COVER TABLE 44" X 90" LIF (1) NEEDLE HYPODERMIC 18G X 1 % LIF (1) SYRINGE 10cc WITHOUT NEEDLE L...
Surgical Devices·4 affected·May 20, 2014
CriticalFDA
Customed, Inc
C-SECTION PACK - (1) TABLE COVER REINFORCED 50" X 90" L/F (3) TOWELS ABSORBENT 15" X 20" L/F (1) BABY BLANKET (1 0) GAUZE SPONGE 4" ...
Surgical Devices·30 affected·May 20, 2014
CriticalFDA
Customed, Inc
Breast Augmentation Pack, Imagenes Cosmetic, code 900-2682: (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM (...
Surgical Devices·1 affected·May 20, 2014
CriticalFDA
Customed, Inc
Customed LABOR & DELIVERY PACK - Includes: (1) TABLE COVER 44" x 90" (2) LEGGINS WITH/7" CUFF 30" x 42" (5) ABSORBENT TOWELS 15" x 2...
Surgical Devices·34 affected·May 20, 2014
CriticalFDA
Customed, Inc
ARTHROSCOPY PACK- (2) ABSORBENT TOWELS 15" x 20" LIF (1) TUBE SUCTION CONNECT Y.." X 12' LIF (1) ELASTIC BANDAGE 6" X 5yrd. UF (1) I...
Surgical Devices·11 affected·May 20, 2014
CriticalFDA
Customed, Inc
PERY GYN PACK- (1) DRAPE UTILITY WITH TAPE (1) DRAPE UNDERBUTIOCK WITH POUCH (1) TOWELS ABSORBENT 15" x 20" UF (2) LEGGINS W/7'' CUF...
Surgical Devices·53 affected·May 20, 2014
CriticalFDA
Customed, Inc
UROLOGY PACK- (10) GAUZE SPONGE 4" X 4" 16PLY (1) TUBE SUCTION CONNECT Y." X12' (1) SYRINGE 30cc WITHOUT NEEDLE ULOCK (1) BASIN RI...
Surgical Devices·27 affected·May 20, 2014
CriticalFDA
Customed, Inc
Basic Pack FPSC Florham Pack , code 900-2969, contains: (1) COVER TABLE REINFORCED 50" X 90" (10) GAUZE SPONGE 4" X 4" 16 PLY XRD (1) C...
Surgical Devices·6 affected·May 20, 2014
CriticalFDA
Customed, Inc
Knee Arthroscopy Pack, code 900-2718, contains: (1 0) GAUZE SPONGES 4 X 4 12PL Y (2) PADDING CAST SOFT ROLL 6 X 4yds. (1) GOBAN SELF-A...
Surgical Devices·3 affected·May 20, 2014
CriticalFDA
Customed, Inc
Tummy Tuck Pack-BOD , code 900-3026, contains: (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMIIII (2) TOWELS ABSORBENT 15 X 20 (1) PEN...
Surgical Devices·2 affected·May 20, 2014
CriticalFDA
Customed, Inc
FEMORAL PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" LIF (2) DRAPE SHEET 42" X 57" SMS LIF (1) SAFETY IV INTROCAN 18 X 1X ST....
Surgical Devices·11 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAP AROSCOPY PACK - (10) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (1) MAYO STAND COVER REINFORCED L/F (4) ADHESIVE BANDAGE%" X 3" ST. LIF ...
Surgical Devices·21 affected·May 20, 2014