Bayer Healthcare

Impacted Batch Numbers: 20044 8401230 20110777 20110778 20129053 20130260 20143029 20168043 20168044 20218499 20223554 20226461 20229069 50378230 50508655 50514420 50515055 50515057 50562833 50562834 50562835 50562836 50572481 50574207 50574208 50574209 50585611 50586105 50596605 50597703 50597850 50600435 50601580 50602572 50604785 50606331 50620077 50629437 50632873 50634213 50657181 50663447 50665086 50669881 50677540 50686154 50688724 50693453 50695189 50696540 50696563 50698651 50699741 50699882 50699883 50705397 50705398 50718205 50718756 50720431 50721421 50725617 50725618 50731457 50735273 50738861 50740290 50743615 50747279 50748947 50750243 50752501 50755005 50781643 50782219 50783201 50784811 50786091 50786092 50786096 50789117 50789131 50789132 50792077 50793811 50795111 50798463 50801293 50801294 50804590 50804591 50808994 50812469 50826288 50826491 50826492 50827614 50827615 50828779 50831229 50831230 50833827 50834754 50836287 50837233 50838024 50840343 50840344 50841688 50843787 50845969 50847291 50848267 50848268 50848269 50853167 50855436 50856405 50857510 50860994 50866789 50867921 50869464 50869465 50871131 50872965 50878229 50878230 50878231 50878232 50881328 50881393 50881394 50881395 50881506 50881511 50881512 50882753 50886316 50886467 50886468 50886469 50888285 50888286 50888287 50888373 50890483 50890484 50890485 50892357 50892358 50892359 50892360 60000321 60000790 60000833 60000835 60000914 60000973 60001065 60001078 60001558 60001766 60001767 60001864 60002113 60002164 60002324 60002467 60002845 60002846 60003127 60003128 60003256 60003265 60003368 60003703 60004022 60004099 60004159 60004454 60004625 60004711 60005487 60006206 60006545 60006624 60007219 60007220 60007221 60007925 60008270 60008271 60008539 60008540 60008541

General Hospital and Personal Use Devices

2

No

Distributed Nationwide and internationally to : Taiwan, Ukraine, Turkey, Thailand, Slovania, Singapore, Sweden, Saudi Arabia, Serbia, Romania, Qatar, Portugal, Poland, Panama, Oman, Norway, The Netherlands, Mexico, Malta, Morraco, Libyan, Lithuania, Lebanon, Kuwait, Italy, Israel, Hungray, United Kingdom, France, Finland, Spain, Denmark, Germany, Czech Republic, Chile, Switzerland, Belguim, Bosnia, Austria, Australia,

PET Infusion Pump

Serial Numbers:  KSA0517595 KSA0518535 KSA0519948 KSA0518539 KSA0518498 KSA0517618 KSA0518500D KSA0518536 KSA0518456 KSA0518504 KSA0518520 KSA0519940 KSA0518507 KSA0519991 KSA0517568 KSA0517592 KSA0517649 KSA0518496 KSA0518508 KSA0519971 KSA0518534 KSA0517600 KSA0517566 KSA0517587 KSA0518469 KSA0518452 KSA0518460 KSA0518532 KSA0518516 KSA0519946 KSA0517641 KSA0519968 KSA0519941 KSA0518399 KSA0518479 KSA0517609 KSA0517617 KSA0518446 KSA0518453 KSA0518410 KSA0518466 KSA0517581 KSA0517574 KSA0518524 KSA0519956 KSA0518459 KSA0518495 KSA0518481 KSA0518513 KSA0518528 KSA0519989 KSA0518429 KSA0518523 KSA0517620 KSA0518509 KSA0517634 KSA0519964 KSA0518418 KSA0518474 KSA0518526 KSA0518468 KSA0518499 KSA0518463 KSA0517571 KSA0517648 KSA0517564 KSA0517644 KSA0518423 KSA0517582 KSA0518427 KSA0518518 KSA0518419 KSA0518397 KSA0518505 KSA0518522 KSA0517660 KSA0518492 KSA0519955 KSA0517629 KSA0518461 KSA0519951 KSA0518471 KSA0517597 KSA0517565 KSA0517656 KSA0518506 KSA0517607 KSA0517659 KSA0518491 KSA0517632 KSA0519978 KSA0517590 KSA0517612 KSA0517613 KSA0518447 KSA0518424 KSA0518400 KSA0519939 KSA0518431 KSA0518435 KSA0518515 KSA0518490 KSA0517624 KSA0518455 KSA0517661 KSA0518493 KSA0519945 KSA0517575 KSA0517588 KSA0517616 KSA0517653 KSA0517657 KSA0517658 KSA0518449 KSA0519982 KSA0519959 KSA0518426 KSA0519984 KSA0519976 KSA0519952 KSA0518511 KSA0518540 KSA0517584 KSA0517651 KSA0519947 KSA0518413 KSA0518405 KSA0518502 KSA0519954 KSA0519980 KSA0518531 KSA0518443 KSA0518529 KSA0519972 KSA0518510 KSA0517637 KSA0519990 KSA0518484 KSA0517602 KSA0518437 KSA0518477 KSA0517583 KSA0518530 KSA0518412 KSA0517577 KSA0519958 KSA0518442 KSA0518525 KSA0517635 KSA0517662 KSA0519957 KSA0519961 KSA0519981 KSA0518521 KSA0517646 KSA0518464 KSA0517576 KSA0518420 KSA0518433 KSA0519960 KSA0518414 KSA0517596 KSA0519970 KSA0518473

Cardiovascular Devices

2

No

Worldwide Distribution - US (nationwide) and Internationally to United Arab Emirates, Australia, Canada, Germany, Spain, and United Kingdom.

Certegra Workstation used in conjunction with Medrad Stellant CT Injection System || Catalog Number # CWKS DISPLAY || Serial Numbers || The Medrad Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications

Catalog numbers: ART 700 PEDL, ART 700 TABL, ART 700 OCS, which utilize Software Version SW 005.006_SH.  Affected serial numbers: 20329, 20570, 101148, 20392, 20425, 20427, 30046, 100945, 100186, 21255, 30086, 20025, 101153, 101159, 20714, 100873, 20437, 100033, 100249, 20333, 100511, 101206, 100002, 100890, 101208, 20323, 20914, 20342, 10172, 10074, 20195, 20196, 20850, 20929, 101106, 30020, 30024, 30033, 20252, 10087, 20851, 100009, 100864, 100335, 10095, 20302, 20306, 100013, 20918, 100141, 20158, 100784, 20735, 20422, 101149, 20842, 20018, 101114, 100056, 100075, 20434, 21024, 20311, 20763, 10055, 20786, 20701, 20729, 20040, 100092, 20501

Cardiovascular Devices

2

No

Worldwide Distribution. US Nationwide, Germany, France, UK, Netherlands, Sweden, and Canada.

Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.

Device Listing # D053816

General Hospital and Personal Use Devices

2

No

Nationwide Distribution

MEDRAD Intego PET Infusion System - Pump || Intended to deliver accurate doses of Fluoredeoxyglucose or F-Sodium Fluoride and commonly used flushing solutions to patients during molecular imaging (nuclear medicine) diagnostic procedures. It is also intended to provide effective radiation shielding to medical personnel from Fluorine-18 radiation exposure during nuclear medicine diagnostic procedures.

Catalog numbers: MRXP 200 Serial numbers: 100009, 100011, 100019, 100020, 100022, 100026, 100027, 100028, 100036, 100047, 100065, 100066, 100069, 100074, 100075, 100085, 100090, 100091, 100096, 100097, 100098, 100099, 100100, 100101, 100103, 100104, 100106, 100107, 100108, 100109, 100110, 100111, 100112, 100113, 100114, 100118, 100119, 100129, 100152, 100155, 100161, 100166

Cardiovascular Devices

2

No

Worldwide and the US state of NEW YORK

Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable MRI Kit || Usage: || The MEDRAD MRXperion MR Injection System is a syringe based fluid delivery system indicated for delivery of contrast media and saline during MR applications. It is intended to be used for the specific purpose of injecting intravenous MR contrast media and saline into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) applications with MRI scanners that have a magnetic field strength between 0.7 and 3.0 Tesla. Only trained healthcare professionals are intended to operate this device.