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All Recalls

Every Customed, Inc Recall

Sorted by most recent. Click any recall for full details.

452 recalls
CriticalFDA
Customed, Inc
Wound Management Tray II, Catalog number 900-1198. Used by medical staff to perform patient care procedures such as wound healing, sut...
Medical Devices·28,020 affected·Oct 8, 2014
CriticalFDA
Customed, Inc
Laparotomy Pack, 900-2516, pack contains: ( I) TABLE COVER44" X 90" ( I) CAUTERY PENCIL PUSH BOTTOM (4) TOWELS ABSORBENT 15" X 20" L/...
Surgical Devices·2 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAPAROSCOPY COLORECTAL SURGICAL PACK code 900-2259A, contains: (1) SOLUTION SURGICAL DURAPREP 26ml LIF (4) DRAPE UTILITY WITH TAPE LI...
Surgical Devices·3 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAPAROSCOPY PACK- - (1) DRAPE LAP ABDOMINAL WITH POUCH (1) CAMARA DRAPE 9" X 96" LIF (5) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND C...
Surgical Devices·19 affected·May 20, 2014
CriticalFDA
Customed, Inc
ARTHROSCOPY PACK I (1) CUSTOMED CONTENTS: (1) TOWELS ABSORBENT 15" X 20" (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) MAYO STAN...
Surgical Devices·4 affected·May 20, 2014
CriticalFDA
Customed, Inc
PEDIATRIC LAP PACK - ( I) SHEET MINOR LAP 102" X 121" X 78" ( I) MAYO STAND COVER REINFORCED LIF ( I) TABLE COVER REINFORCED 50" X 90...
Surgical Devices·32 affected·May 20, 2014
CriticalFDA
Customed, Inc
PREMIUM OPHTHALMIC PACK- CUSTOMED- (1) GOWN SMS X-LARGE STD RAGLAN (1) CUP MEDICINE 2oz (1) DRAPE OPHTHAL. WITH POUCH LIF (1 0) SPO...
Surgical Devices·7 affected·May 20, 2014
CriticalFDA
Customed, Inc
FOLEY CATHETER KIT 1116FR. - CUSTOM ED- (1) WRAPPER 24" X 24" (1) PVP TRIPLE SWABSTICK IODOPHOR (2) GLOVE MED FREETOUCH VYNIL P/F ...
Surgical Devices·27 affected·May 20, 2014
CriticalFDA
Customed, Inc
ACDFPACK SURGICAL CENTER, CODE 900-2917. CONTENTS: (1) SOLUTION SURGICAL DURAPREP 6ML LIF (4) Prs. GLOVE SURG. DERMA PRENE # 8 PF...
Surgical Devices·6 affected·May 20, 2014
CriticalFDA
Customed, Inc
UMBILICAL VESSEL CATHETER KIT - CUSTOMED- (1) PAPER TAPE MEASURE DISP. 24" (1) FENESTRATED DRAPE 18" x 26" LIF (1) NEEDLE HOLDER BAU...
Surgical Devices·7 affected·May 20, 2014
CriticalFDA
Customed, Inc
Shoulder Pack, Code 900-2616, contains: (2) TUBE SUCTION CONNECT Y."X12' UF (1) SYRINGE 20CC W/0 NDL UL UF (2) DRAPE VIDEO CAMERA UF ...
Surgical Devices·4 affected·May 20, 2014
CriticalFDA
Customed, Inc
Liposuction Pack MRT, code 900-2656, contains: (1) NEEDLE HYPODERMIC 27 X 1 LIF (1) UTILITY BOWL QUART 32oz LIF (1) MAYO STAND COVER ...
Surgical Devices·1 affected·May 20, 2014
CriticalFDA
Customed, Inc
ANGIOGRAPHY PACK CONTENTS: (4) CLOTH HUCK TOWEL BLUE (1) TABLE COVER REINFORCED 50" x 90" LIF (2) SYRINGE 20cc WITHOUT NEEDLE LUER ...
Surgical Devices·21 affected·May 20, 2014
CriticalFDA
Customed, Inc
RETINA PACK - (1) TABLE COVER REINFORCED 44" X 78" LIF (50) COTTON TIP APPLICATOR 6" WOOD LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED LA...
Surgical Devices·10 affected·May 20, 2014
CriticalFDA
Customed, Inc
CESAREAN PACK - - (7) TOWELS ABSORBENT 15" X 20" (2) SCALPEL WEIGHTED SAFETY #1 0 (1) BLANKET BABY 30" X 30" POLY ABS IMP (1) BOWL...
Surgical Devices·30 affected·May 20, 2014
CriticalFDA
Customed, Inc
Customed O.B. Pack convenience pack include multiple components: set up cover, absorbent towel, ear ulcer syringe, pad, umbilical cord ...
Surgical Devices·24 affected·May 20, 2014
CriticalFDA
Customed, Inc
Customed Femoral Pack , convenience pack include multiple components: Syringe 3cc, 5cc, 10cc, 20cc; swabstick chlorascrub, needles, gauze...
Surgical Devices·14 affected·May 20, 2014
CriticalFDA
Customed, Inc
Urology Pack, 900-2510, package contains: (2) TOWELS ABSORBENT 15X 20 UF (1) DRAPE LITHO 11 0" X 63" W/LEGG/POUCH FEN UF (10)GAUZE SP...
Surgical Devices·10 affected·May 20, 2014
CriticalFDA
Customed, Inc
ORTHOPEDIC SURGICAL PACK HOSPITAL SAN CRISTOBAL CONTENTS: (I) CAUTERY TIP POLISH ER LIF (1) BAG SUTURE FLORAL (1) TUBE SUCTIO...
Surgical Devices·7 affected·May 20, 2014
CriticalFDA
Customed, Inc
O.B. PACK - (I) TABLE COVER REINFORCED 50" X 90" LIF (I) DRAPE UNDERBUTTOCK WITH POUCH 44" X 35" (2) LEGGINS W/7'' CUFF 30" X 42" (1...
Surgical Devices·49 affected·May 20, 2014
CriticalFDA
Customed, Inc
ARTHROSCOPY PACK - - (1) MAYO STAND COVER REINFORCED LIF (3) TOWELS ABSORBENT 15" X 20" LIF (1) STOCKINETTE IMPERVIOUS 14" X 48" LIF...
Surgical Devices·20 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAPAROSCOPY PACK - (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR LIF (1) DRAPE ENDOSCOPY 1 00" X 123W' X 77" WITH TROUGHS (1) MAYO STA...
Surgical Devices·18 affected·May 20, 2014
CriticalFDA
Customed, Inc
VAGINAL PROCEDURE PACK CUSTOM ED CONTENTS: (1) DRAPE LITHOTOMY 110" X 63" W/LEGGINGS I POUCH FEN 3 X 6 SMS LIF (1) GOWN XL SMS...
Surgical Devices·7 affected·May 20, 2014
CriticalFDA
Customed, Inc
Laparoscopy pack, , Code 900-3178, contains: (1) BULB SYRINGE 60cc LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) MAYO STAND COVER RE...
Surgical Devices·4 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAPAROSCOPY CHOLE PACK - (4) DRAPE UTILITY WITH TAPE LIF (2) ABSORBENT TOWELS 15" X 20" LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LA...
Surgical Devices·16 affected·May 20, 2014
CriticalFDA
Customed, Inc
FOLEY CATHETER KIT 1118FR.- CUSTOM ED CONTENTS: (1) WRAPPER 24" X 24" (1) LABEL ID PATIENT (1) TRAY ORGANIZER (1) PVP TRIPLE SWABS...
Surgical Devices·13 affected·May 20, 2014
CriticalFDA
Customed, Inc
Cirugia Cardiovascular Case Cart, c ode 900-1415A, contains: (1) CIRUGIA CARDIOVASCULAR .(INDUCCION) (1) CIRUGIA CARDIOVASCULAR (CIRUGI...
Cardiac Devices·7 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAPAROTOMY PACK - (I) UTILITY BOWL 16oz ( I) ELECTRODE DUAL DEPRES./GROUNDPAD (I) UTILITY BOWL 32oz ( I) GOWN IMP. REINFORCED XL SMS...
Surgical Devices·3 affected·May 20, 2014
CriticalFDA
Customed, Inc
Liposuction Pack BOD, code 900-3028, contains: (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill (2) LITE GLOVES LIF (2) TOWEL ABSORBENT ...
Surgical Devices·2 affected·May 20, 2014
CriticalFDA
Customed, Inc
MINOR LAPAROTOMY PACK - (1) TABLE COVER 50" X 90" REINFORCED LIF (1) GOWN SURG. X-LARGE REINFORCED TOWEL/WRAP (1) GOWN X-LARGE SMS I...
Surgical Devices·50 affected·May 20, 2014
CriticalFDA
Customed, Inc
NEURO PACK CONTENTS: (4) TOWEL ABSOSRBENT 15" X 20" LIF ( I ) BAG BI OH AZARD 30" X 37" (2) MAYO STAND COYER REINFORCED UF (2...
Surgical Devices·12 affected·May 20, 2014
CriticalFDA
Customed, Inc
CERVICAL PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER TABLE REINFORCED 50" X 90" (1) COVER FLUORO 30" X 30" WITH R...
Surgical Devices·2 affected·May 20, 2014
CriticalFDA
Customed, Inc
PREMIUM UROLOGY PACK - CUSTOMED- (1) LITHOTOMY DRAPE W/POUCH ANESTH. (2) ABSORBENT TOWELS UF (1) MAYO STAND COVER REINFORCED UF (1...
Surgical Devices·2 affected·May 20, 2014
CriticalFDA
Customed, Inc
Face Pack MRT, product code 900-2654, contains: (2) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE LIF (2) TOWELS ABSORBENT 15 X 20 LIF (1) D...
Surgical Devices·2 affected·May 20, 2014
CriticalFDA
Customed, Inc
OPHTALMIC PACK - (1) GOWN LGE SMS NON REINF TIWRAP (1) IODINE POVIDONE 1oz. (2) TOWEL ABSORBENT 15" x 20" UF (1) SYRINGE 3cc W/...
Surgical Devices·25 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAPAROSCOPIA COLORECTAL PACK CONTENTS: (1) SOLUTION SURGICAL DURAPREP 26ml (4) DRAPE UTILITY WITH TAPE (1) TOWELS ABSORBENT 15...
Surgical Devices·17 affected·May 20, 2014
CriticalFDA
Customed, Inc
BASIC PACK - (1) TABLE COVER REINF. LIF (1) MAYO STAND COVER REINF. LIF (2) TOWELS ABSORBENT LIF (10) GAUZE SPONGES XRD 4" X 4" 12...
Surgical Devices·1 affected·May 20, 2014
CriticalFDA
Customed, Inc
TLIF PACK SURGICAL CENTER, CODE 900-2918. CONTENTS: (2) SOLUTION SURGICAL DURAPREP 26ML UF (6) Pr. GLOVE SURG. DERMA PRENE # 8...
Surgical Devices·8 affected·May 20, 2014
CriticalFDA
Customed, Inc
08 PAD PACK II (2,3) CUSTOMED CONTENTS: (3) TOWEL ABSORBENT 15" X 20" (1) BOWL W/LID PLASTIC 80oz (1) GOWN XL SMS IMPERVIOUS REINFOR...
Surgical Devices·3 affected·May 20, 2014
CriticalFDA
Customed, Inc
ORTHO PACK EXTREMITY CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 50" X 90" (1) MAYO STAND COVER REINFORCED (1) SUTURE BAG FLOR...
Surgical Devices·3 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAP Abdom w/pouch Customed code 900-2619, contains: (1) DRAPE LAP. ABDOM W/POUCH 102" X 122" X 78" (1) WRAPPER 30" X 30" Product Usa...
Surgical Devices·2 affected·May 20, 2014
CriticalFDA
Customed, Inc
OB PACK - (2) EXAM GLOVES MED. (1 0) GAUZE SPONGES 4" X 4" 12PL Y (2) LEGGINS W/ 7" CUFF (2) DRAPE SHEET SMS (1) ABDOMINAL DRAPE W/...
Surgical Devices·1 affected·May 20, 2014
CriticalFDA
Customed, Inc
Gown Impervious , Code 900-3190, contains: GOWN IMPERVIOUS EXTRA LONG X-LARGE WITH TOWEL & WRAP Product Usage: EO sterilized surgical...
Surgical Devices·5 affected·May 20, 2014
CriticalFDA
Customed, Inc
Liposuction Pack, code 900-2681, contains: (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE (1) TUBE SUCTION CONNECT (1) MAYO STAND COVER REIN...
Surgical Devices·1 affected·May 20, 2014
CriticalFDA
Customed, Inc
Drape Sheet, Product Code 2942, contains (1) DRAPE % ECONOMY 53 X 77L/F (1) WRAPPER 24 X 24 L/F Product Usage: EO sterilized surgical...
Surgical Devices·3 affected·May 20, 2014
CriticalFDA
Customed, Inc
OPHTALMIC PACK- (1) TABLE COVER REINF. 44" X 78" UF (1) GOWN SMS XLGE STD UF (2) TOWEL ABSORBENT 15" X 20" LIF (1) SYRINGE 3cc W/0...
Surgical Devices·20 affected·May 20, 2014
CriticalFDA
Customed, Inc
BASIC PACK 1 (Ill) CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 44" X 78" (4) DRAPE UTILITY WffAPE (2) TOWELS ABSORBENT 15" X 20" (1...
Surgical Devices·5 affected·May 20, 2014
CriticalFDA
Customed, Inc
STRABISMUS & PLASTIC PACK - (1) TABLE COVER REINFORCED 44" X 78" UF (2) GOWN STANDARD LARGE SMS (3) TOWELS ABSORBENT 15" X 20" UF (1) ...
Surgical Devices·46 affected·May 20, 2014