11 results
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18ms
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Sources: EU EUDAMED, US FDA
AFFINITY BED MODEL 3600 SERIES
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DISPOSABLE ELECTROSURGICAL BLADE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ALDETECT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BLOWER MISTER WITH IV SETS
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GCJ·June 12, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·January 15, 2013
ACCOLADE 132 SIZE 4.5
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MEH·November 29, 2010
Cardiovascular Split Sheet II, Bulk Non-Sterile; 130 units per box; Cardinal Health, McGaw Park, IL 60085-6787, Made in Mexico; catalog #9158N
FDA Recall
Terminated
·Cardinal Health·Product code KKX·September 27, 2006
Convertors Cardiovascular Split Pack II, the pack contains 1 Tiburon Cardiovascular Split Drape II and 3 Astound Surgical Gowns; Sterile, for single use only; Cardinal Health, McGaw Park, IL 60085-6787, Made in Mexico; Catalog #29158
FDA Recall
Terminated
·Cardinal Health·Product code LRO·September 27, 2006
Convertors Tiburon Cardiovascular Split Drape II, Sterile, for single use only; Cardinal Health, McGaw Park, IL 60085-6787, Made in Mexico The cardiovascular drapes were packagaged under the following configurations: a) Catalog #9158 - 1 CV split drape b) Catalog #9158CE - 8 x 1 CV split drape
FDA Recall
Terminated
·Cardinal Health·Product code KKX·September 27, 2006
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
Presource Custom Sterile Packs containing the Cardiovascular Split Drape II; the custom sterile packs were packaged with the bulk, non-sterile drapes and then the complete custom pack was sterilized; packaged by Cardinal Health Medical Products and Services, McGaw Park, IL 60085; identified by the following catalog numbers: a) SVC13AMEMK - Sterile Open Heart Adult Pk; b) SCV31OHMPJ - Sterile Open Heart w Drapes Pk; c) SVC42OPVCG - Sterile Open Heart Adult Pack; d) SCV32CPMUO - Sterile CAB 146060 Pack; e) SCV34OHTMJ - Sterile Basin Pack; f) SCV31LVLUM - Sterile Liver Transplant Pack; g) SCV19CVHHF - Sterile Cardiovascular Pack; h) SCV11ADLLD - Sterile Open Heart/Adult; i) SCV92CBHRB - Sterile CABG Pack; j) SCV92CASIA - Sterile Cardiovascular Pack; k) SBA32GSMUL - Sterile General Surgery Pack; l) SCV30OHKWA - Strl **** Open Heart Pack; m) SBA31LVLUM - Sterile Liver Transplant Pack; n) SBA35LTBLQ - Sterile Lung Transplant Pack; o) SCV44CVDEB - Sterile CV Pack; p) SCV22OHMES - Open Heart Pack; q) SCV23AOSFH - Open Heart Part 3; r) SCV43OHHRF - Open Heart; s) SCV24CAGME - CABG Drape Pack; t) SAN12CCKGB - Cardiac Pack; u) SBA13BRBSE - Breast Reduction; v) SCV11CBNYP - CABG G 3; w) SCV11CESLB - C.V. Drape Pack; x) SCV11CGCPR - CABG; y) SCV11CGXXB - CABG Pack; z) SCV11CJICL - Cardiac Major; aa) SCV11CTMUK - C T Set Up; bb) SCV11DPMYG - **** S Drape Pack; cc) SCV11HEMMI - Open Heart A B; dd) SCV11MRCPE - Major Cardiac; ee) SCV11OCNYN - OH CABG; ff) SCV11OHLD2 - Open Heart A&B Pack; gg) SCV11OHNMC - Open Heart; hh) SCV11OPLKC - O P CABG; ii) SCV11VASLB - C V Valve Drape; jj) SCV11VLNYM - G 3 Valve; kk) SCV12OHYHY - Graft and Linen; ll) SCV13AABSV - Aortic Aneurysm; mm) SCV13AMEMJ - Open Heart Pack B; nn) SCV13BBEMC - Cardio-Thoracic Aux; oo) SCV13CB767 - CABG; pp) SCV13OHCAI - Open Heart Pk; qq) SCV13OOBIG - Open Heart Drape; rr) SCV14O1BGO - Open Heart Pack A; ss) SCV22OHPGA - Open Heart Pack; tt) SCV22OOMSE - Open Heart Preferred; uu) SCV24OH20A - Open Heart Drape Pack; vv) SCV43DREJI - Open Heart Drape Pack; ww) SCV69OH17E - Open Heart; xx) SCV59HVSGJ - Heart Valve Pack; yy) SCV59OHNVM - Open Heart Pack; zz) SCV53HTDMG - ***** Open Heart; aaa) SCV56CH11A - Open Heart Pack; bbb) SCV59MJTCW - Open Heart Pack; ccc) SCV52OH97F - Open Heart Pack; ddd) SCV41OHHIE - Open Heart Pack; eee) SCV52HTSJE - Open Heart Pack; fff) SCV59OHMHV - Basic Heart Pack; ggg) SCV11MJTJI - Open Heart
FDA Recall
Terminated
·Cardinal Health·Product code LRO·September 27, 2006