Device Recall Cook Medical

RPN/Catalog number: C-PMS-250-PED C-PMS-251J-PED C-PMS-300-CHILDRENS-032285 C-PMS-301J-PED C-PMS-301J-PED-BH C-PMS-301-PED C-PMSY-250 C-PMSY-251 C-PMSY-251J C-PMSY-300 C-PMSY-300J C-PMSY-300J-UT-A C-PMSY-300-PED C-PMSY-301J C-PMSY-301J-BH C-PMSY-301J-PED C-PMSY-301J-PED-OTP C-PMSY-400-HURLEY-022388 C-PUM-300J C-PUM-301 C-PUM-301J C-PUMY-301J  Lots: NS6168054 NS6178118 NS6063352 NS5855441 5824486 5898058 5967405 6079119 NS5932737 NS6028554 NS6042799 NS5922707 NS5932811 NS6145002 5987014 NS6178099 NS6028540 NS5830758 NS5866960 NS5918174 NS5974263 NS6042577 NS6047450 NS6090278 NS6105922 NS6124990 NS5881337 NS5892116 NS6031991 5782006 5855241 NS5881336 NS5892113 NS5945282 6062729 NS5970950 NS6108255 NS6153173 5793198 5925744 6010406 6148800 NS5796483 NS5928602 NS6047451 NS5970942 NS5954223 5945120 NS5954224 5973354

Cardiovascular Devices

2

No

Worldwide Distribution - US Nationwide including DC and PR including the countries of Australia, Germany, China, Chile, Dominican Republic, Panama, Israel, Brazil, Canada

Single Lumen Central Venous Catheter Sets and Trays || The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.

RPN/Catalog number: C-PMS-250 C-PMS-2502-15-3.5 C-PMS-2502-15-5.0 C-PMS-250-MONTES-A-092084 C-PMS-251 C-PMS-251J C-PMS-300 C-PMS-300-CHILDRENS-A-032988 C-PMS-300J C-PMS-301 C-PMS-301J C-PMS-301J-PKG C-PMS-400J  Lots: 6028502 6034979 6083984 6194848 NS6014456 NS6014457 6148788 6254047 5906417 6160213 NS6064797 NS6014483 NS6175149 NS6184593 NS6187516 NS6014458 5889463 5898283 5922849 5941909 5964565 5976506 6021072 6028497 6143834 6160238 NS5933957 5828147 5941919 NS5932835 NS5932836 NS6050233 NS6072523 NS6108227 NS6130497 5803601 6034985 6075213 NS5833882 NS5892109 NS5892110 NS5919920 NS6021136 NS6054843 NS6072524 NS6075557 NS6082375 NS6108228 NS6148658 6067668

Cardiovascular Devices

2

No

Worldwide Distribution - US Nationwide including DC and PR including the countries of Australia, Germany, China, Chile, Dominican Republic, Panama, Israel, Brazil, Canada

Single Lumen Pressure Monitoring Sets and Trays || The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.

RPN/Catalog number: C-PMS-250-RA C-PMS-251-RA C-PMS-300-RA C-PMS-300-RA-CHOP C-PMS-301J-RA C-PMS-301-RA C-PMS-400-RA C-PMSY-250-RA C-PMSY-300-RA C-PMSY-301-RA  Lots: 6049998 6160195 6160212 NS5898558 NS6063328 NS6178204 NS6178206 5895605 6191185 5793196 5800313 5800443 5800569 5806981 5810905 5810917 5824484 5824546 5824547 5824548 5866984 5866985 5866986 5870319 5881447 5881519 5889496 5891905 5911486 5922847 5922848 5925742 5928632 5939446 5939447 5939448 5976502 6025016 6025094 6033768 6034981 6034983 6050000 6062738 6062742 6067675 6067676 6075206 6075207 6083936 6083954 6083985 6083986 6129056 6148790 6160236 6165591 6174974 6175289 6191362 6269150 NS6063331 NS6108226 NS6170739 NS6170767 5905252 6003109 NS6072553 5793197 5800571 5800572 5824485 5824551 5845063 5864072 5866988 5873125 5881151 5881152 5884641 5884642 5889464 5892063 5892064 5922850 5939431 5942091 5951549 5953768 5954322 5967404 5974281 5994817 5996926 6003161 6003162 6017048 6025095 6025145 6034984 6042699 6050002 6075210 6075211 6075212 6081723 6083988 6100756 6124809 6125111 6148791 6153122 6160239 6160240 6168131 6171368 6187477 6250532 6059759 NS6047396 NS6047397 NS6047398 NS6047399 NS6047440 NS6047442 6124812 5793192 5824526 5884647 5892068 5942090 5967410 6003167 6059765 6134128 6153124 6168137 6254068 5793193 5866995 5892069 5942092 6003168 6025099 6067664 6168138

Cardiovascular Devices

2

No

Worldwide Distribution - US Nationwide including DC and PR including the countries of Australia, Germany, China, Chile, Dominican Republic, Panama, Israel, Brazil, Canada

Radial Artery Pressure Monitoring Catheter Sets and Trays || The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.

Lot Number: U1753668.

Gastroenterology-Urology Devices

2

Yes

Nationwide Distribution including states of Georgia, Oregon and Texas.

Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating, 5.0Fr/26cm, sterile, Cook Urological Inc., Spencer, IN; REF USH-526-R, GPN REF G49966. The product was placed in a shipping box which is preprinted with the word "firm" instead of "soft", but a product specific label stating "soft", as above, was also placed on the box. || The ureteral stent is used for temporary drainage from the ureteropelvic junction to the bladder.