1,179 results
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19ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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DeRoyal TOTAL HIP TRACECART, REF 53-1820.14, Rx ONLY, NON-STERILE. Custom surgical kit containing Stryker CBCII Blood Conservation Kit.
FDA Recall
Terminated
·DeRoyal Industries Inc·Product code LRO·December 9, 2009
Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal Health, McGaw Park, IL 60085; The kit catalog numbers listed in the code information section below contain one or more of the following listed components for which Cardinal Health has been unable to confirm the manufacturer's compliance with section 502(o) of the FD&C Act: a) Split Dressing - 2"x 2", Yellow, component C-033-0022, vendor part number S1072; b) Tubing Extension Sets and IV Sets component C-FG711297CP, vendor pn FG711297CP; component C-FG711093CP, vendor pn FG711093CP; component C-FG711298CP, vendor pn FG711298CP; component C-FG711092CP, vendor pn FG711092CP; c) Cast Padding component C-9046, vendor pn 9046; component C-9044, vendor pn 9044; component C-9043, vendor pn 9043; component C-9062, vendor pn 9062; d) Scalpel Holder component C-DD1628-6, vendor pn DD1628-6; e) Latex Tubing component C-806-12, vendor pn 806-12; component C-808R, vendor pn 808R; component C-606R, vendor pn 606R; component C-122BA10, vendor pn 122BA10; component C-122BA12, vendor pn 122BA12; component C-122BA07, vendor pn 122BA07; component C-102BA12, vendor pn 102BA12; component C-099BA10, vendor pn 099BA10; component C-102BA10, vendor pn 102BA10; component C-103BA10, vendor pn 103BA10; component C-124BA10, vendor pn 124BA10; component C-140BA10, vendor pn 140BA10; f) Clinic Dropper component C-12548, vendor pn 10-871-00; g) Tongue Blade (depressor) component C-11820-010, vendor pn 07-920-00; h) Catheter Clamp component C-043-0497, vendor pn 033403-887; i) Gillette Good News Razor component C-P4417A, vendor pn 4417GN; j) Prepsicle Round Short Blue Swabstick component C-051-0401, vendor pn SBR20035; k) Tubing component C-SFM3-3050, vendor pn SFM3-3050; component C-SFM3-3650, vendor pn SFM3-3650; l) Specimen Container component C-B9021YN, vendor pn B9021YN; component C-C8846-18, vendor pn 15706-806; The kits are custom packed with all of the specific disposable class 1 and 2 devices required by the customer for specific types of surgery and medical procedures. These packs are then sterilized and are ready to be used by the customer for the specific procedure.
FDA Recall
Terminated
·Cardinal Health·Product code LRO·September 3, 2011
CMS-8450-R1 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
FDA Recall
Terminated
·Custom Medical Specialties, Inc.·Product code LRO·September 30, 2011
CMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
FDA Recall
Terminated
·Custom Medical Specialties, Inc.·Product code LRO·September 30, 2011
Contra-Angle Torque Driver Kit For Certain and External Connection Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
FDA Recall
Terminated
·Biomet 3i, LLC·Product code LRO·July 22, 2013
UROLOGY PACK- (10) GAUZE SPONGE 4" X 4" 16PLY (1) TUBE SUCTION CONNECT Y." X12' (1) SYRINGE 30cc WITHOUT NEEDLE ULOCK (1) BASIN RING (1) TUR Y SET, 2 LEAD, ST. (1) BAG SUTURE FLORAL (1) GOWN SURG. REINF. XL EXTRA LONG LEVEL IV (2) TOWEL CLAMP (1) DRAPE LITHOTOMY W/LEGGIN I POUCH UF 11 0" x 63" (2) SHEET DRAPE 41 " X 58" SMS (1) COVER TABLE REINF 50" X 90" (1) BAG URINARY DRAINAGE 2000ML ANTI-REFLUX (3) TOWELS ABSORBENT 15" X 20" (1) GOWN IMP. SMS EXTRA REINF. XL T/WRAP LEVEL IV (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) TIME OUT BEACON NON WOVEN ST. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code LRO·May 20, 2014
Tummy Tuck Pack- FJG, code 900-3114, contains: (2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWEL ABSORBENT 15" X 20" (1) PENCIL CAUTERY PUSH BOTIOM ST. HOLSTER (1) NEEDLE HYPODERMIC 22G X 1 Y2 (2) SYRINGE 20CC WITHOUT NEEDLE LUER LOCK (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG (2) BOWL UTILITY QUART 32oz. (1) COVER MAYO STAND REINFORCED (2) MARKER SKIN WITH RULER (1) RULER (1) COVER TABLE REINFORCED 50" X 90" (2) CUP DENTURE 8oz TEAL WITH LID (6) TOWEL CLOTH HUCK BLUE (1) TUBE SUCTION CONNECT X" X 12' (1) YANKAUER SUCTION TUBE WITHOUT VENT (1) SHEET% DRAPE REINFORCED 60" X 77" (4) DRAPE UTILITY WITH TAPE (1 0) LAP SPONGE PREWASH 18" X 18" XRD (1) BLADE SURG. #15 CARBON STEEL (1) BLADE SURG. #1 0 CARBON STEEL (1) SYRINGE BULB 60cc (2) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #6.5 P/F (2) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #7 P/F (1) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #7.5 P/F (1) SKIN STAPLE 35 WIDE (1) DRAPE TOP WITH ADHESIVE 108" X 50" STD SMS (2) DRAPE SIDE 42" X 76" WITH TAPE (1) DRAPE BOTIOM ABS REINFORCED 71" X 62" STD SMS WITH TAPE (1 0) GAUZE SPONGE 4" X 4" 16 PLY (1) PK. STRIP STERI CLOSURE W X 4" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code LRO·May 20, 2014
Gown Cool Impervious XLGE Breathable Customed, 900-2592: (1) GOWN XL SURGICAL MICROCOOL (1) WRAPPER 24" X 24" (1) TOWELS ABSORBENT 15" X 20" LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code LRO·May 20, 2014
EXTREMITY ARM PACK CONTENTS: (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) GOBAN SELF-ADHERENT WRAP 6" X 5yds (3) BANDAGE ELASTIC 4" X 5yds (1) BANDAGE ESMARK 6" X 9 (1) UTILITY BOWL QUART 32oz (10) GAUZE SPONGE 4" X 4" 16PLY (1) TUBE SUCTION CONNECTX 12' (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (3) SCALPEL WITH HANDLE# 15 STAINLESS STEEL (1) TIME OUT BEACON NON WOVEN (1) LIGHT SHIELD (1) DRAPE INCISE ANTIMICROBIAL 23" X 17" (2) NEEDLE & BLADE COUNTER 10c MAG/CLEAR (1) U-DRAPE 60"X 70" WITH TAPE SPLIT 6" X 21" (1) NEEDLE SPINAL ANESTH 18G X 3% (3) GOWN X-LARGE IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED (4) DR APE UTILITY WITH TAPE (6) TOWEL ABSORBENT 15" X 20" (3) DRAPE % ECONOMY 53" X 77" (1) YANKAUER OPEN TIP CLEAR W/0 CN (1) CAUTERY TIP POLISHER (1) SUTURE BAG FLORAL (1) GOWN SURG REINFORCED X-LARGE TOWEL & WRAP (1) MERLING SKIN PREP APPLICATOR 39ML (1) SHEET HAND 146" X 104" X 91" (1) TABLE COVER REINFORCED 50" X 90" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code LRO·May 20, 2014
BASIC PACK IV (6) CUSTOMED CONTENTS: (3) TOWELS ABSORBENT 15" X 20" (1) MAYO STAN COVER REINFORCED (1) DRAPE % ECONOMY 53" X 77" (1) DRAPE SHEET 41" X 58" SMS (4) UTILITY DRAPE W/TAPE (1) SUTURE BAG FLORAL (1) TABLE COVER REINFORCED 44" X 78" (2) GOWN SOFT SMS STD, XLGE SET IN SLEEVE Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code LRO·May 20, 2014
Plastic Pack Customed, code 900-2582 (1) GOWN LGE SMS IMP REINF L/F (1) GOWN SURG. REINF LGE TMJRAP LIF (1) MAYO STAND COVER REINF LIF (1) TABLE COVER REINF 50" X 90" LIF (4) (1) PVP PAINT 8" STICK SPONGE (2) DRAPESHEET 41X AMED LIF (3) TOWELS ABSORBENT 15 X 20 LIF (2)DRAPE UTILITY Rape LIF (1) BLADE SURGICAL15 S/STEEL (10) GAUZE SPONGE 4 X 4 16 PL Y (20) APPLICATOR COTOIN 6 WOOD Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code LRO·May 20, 2014
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) COVER MAYO STAND REINFORCED (2) GOWN SOFT SMS STD. X-LARGE AAMI Ill (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG (2) TOWELS ABSORBENT 15" X 20" (4) DRAPE UTILITY WITH TAPE (1) WRAPPER 24" X 24" (8) LABELS FOR SKIN MARKERS 1.25" X %" (2) LITES GLOVE (1) MARKER SKIN WITH RULER (1) BLADE SURGICAL# 15 CARBON STEEL (1) RULER (5) SPONGE LAP PREWASH 18" X 18" XRD Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code LRO·May 20, 2014
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" LIF (2) DRAPE SHEET 41 " X 58" SMS (2) TOWELS ABSORBENT 15" x 20" LIF (I ) BAG SUTURE FLORAL LIF (4) DRAPE UTILITY WITH TAPE L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code LRO·May 20, 2014
Liposuction Pack, code 900-2681, contains: (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE (1) TUBE SUCTION CONNECT (1) MAYO STAND COVER REINFORCED (1) SKIN MARKER INK W LABEL (2) TABLE COVER REINFORCED 50 X 90 (1) RULER 6 CLEAR (12) TOWELS CLOTH HUCK (BLUE) (1 0) LAP SPONGE PREWASH 18 X 18 XRD (1) CAUTERY TIP POLISHER (20) GAUZE SPONGE 4X 4 12PL Y (4) TOWEL CLAMP (1) Y CONNECTOR (1) CAUTERY PENCIL PUSH BOTTOM (3) DRAPE SHEET 98 X 63 STD SMS Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code LRO·May 20, 2014
Medline Custom Anesthesia Circuit 40in Adult Unilimb Kit (non-sterile), reorder number DYNJAA4315; the kit contains the Nexus Adult Unilimb Circuit - 40'', part C4N012100, along with a 3 liter latex breathing bag, adult large anesthesia mask, gas line and poly bag; Made in USA by Medline Industries, Inc., Mundelein, IL 60060
FDA Recall
Terminated
·Medline Industries, Inc.·Product code LRO·March 18, 2005
Catalog SBA61MJSFH, Sterile Laparotomy Pack, Mfg date 5/21/03, order 101438;
FDA Recall
Terminated
·Cardinal Health·Product code LRO·June 27, 2003
Cardinal Health Sterile Presource PBDS Modules, have Presource Custom Sterile Packs containing the Cardiovascular Split Drape II or a Sterile Convertors Tiburon Cardiovascular Split Drape II bundled in the module; packaged by Cardinal Health Medical Products and Services, McGaw Park, IL 60085; identified by the following catalog numbers: PBDS modules containing catalog 9158: a) PC40OHRJR - Basic Open Heart Kit, RWJ; b) PC40OHRJT - Basic Open Heart Kit, RWJ; PBDS modules containing custom sterile packs: a) PWOCBSBSE - Breast Reduction Kit, pack SBA13BRBSE; b) PC40CGSLK - CABG Kit, ***, pack SCV11CESLB; c) PCOCCGNYO - CABG Kit, ***, pack SCV11OCNYN; d) PCOCOHNME - Open Heart Kit, pack SCV11OHNMC; e) PC40VPSLD - Valve Kit, pack SCV11VASLB; f) PC78OHUVZ - Open Heart Kit, ***, pack SCV56CH11A; g) PC82OH16C - Open Heart Kit, ***, pack SCV59MJTCW; h) PC82OH17O - Open Heart Kit, pack SCV69OH17E; i) PCVROHDMI - Open Heart Kit, pack SCV53HTDMG; j) PC15CGFCL - CABG Kit, ***, pack SCV32CPMUO; k) PCOCOHLLD - Open Heart Kit - Adult, pack SCV11ADLLD; l) PG15OTFCI - General Surgery Kit, Fairview, pack SBA32GSMUL; m) PGCGLRLUP - Liver Transplant Kit 747340, pack SBA31LVLUM; n) PC13OHEMR - Open Heart Adult Pk Kit, pack SCV13AMEMJ; o) PC60CJICX - Cardiac Major Kit, pack SCV11CJICL; p) PCOCOHMMK - Open Heart AB Kit, ***, pack SCV11HEMMI; q) PCV2CG34A - G 3 CABG Kit, ***, pack SCV11CBNYP; r) PCV2CP10J - CABG Kit, ***, pack SCV11CGCPR; s) PCV2VRNHW - G 3 Valve Kit, ***, pack SCV11VLNYM; t) PVOCAA76F - AAA Kit, ***, pack SCV13AABSV u) UCV42OPVC3 - *** Open Heart Kit, pack SCV42OPVCG; v) PC92CBHRB - *** CABG 2 of 2 Kit, pack SCV92CBHRB; w) PC44CGDEB - *** CV Kit, pack SCV44CVDEB; x) PC22OHMHW - *** Open Heart Kit, pack SCV22OHMES; y) PC23OPSFH - *** Open Heart Kit, pack SCV23AOSFH; z) PC43OHHRG - *** Open Heart Kit, pack SCV43OHHRF; aa) PV24CAGME - *** CABG Kit, pack SCV24CAGME; bb) PC40OHTJI - Open Heart Kit, pack SCV11MJTJI
FDA Recall
Terminated
·Cardinal Health·Product code LRO·September 27, 2006
Medline Total Knee CDS; a single patient prescription procedure pack and disposables, including a back table cover; Product Usage: This Complete Delivery Systems (CDS) custom pack includes components necessary for a total knee replacement surgical procedure.
FDA Recall
Terminated
·Medline Industries Inc·Product code LRO·September 20, 2012
Bandeja para Debridacion (Debridement Tray), Catalog #900-2702 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code LRO·October 8, 2014
Laparotomy Surgical Pack, catalog #900-281A Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code LRO·October 8, 2014