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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1023-2016

Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I¿ H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack. This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass procedures

Publicado el 9 de marzo de 2016 · Inicio del retiro: 4 de febrero de 2016

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tubing Packs that include the potentially affected cuvettes manufactured by Terumo Cardiovascular Systems (Terumo CVS). Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I¿ H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Medtronic Perfusion Systems
Distribuidor
Worldwide Distribution - US including US: AK, AZ, CA, DE, FL, HI, IL, LA, MD. MA. MN, MS, MO, NE, NJ,. NHY, NC, ND, OH, OR, PAM TN, TX, VA, WA, WV, and WI. Internationally to Australia, Belgium, Canada, Czech Republic, Denmark, Dominican Republic, France, Germany, Israel, Japan, Netherlands, Serbia, South Africa, and Switzerland.
Lote
Catalog No. Lot Number UPN / GTIN BB8B09R4 209857492 00643169624436 BB8B09R4 210031260 00643169624436 BB8B09R4 210258522 00643169624436 BB8S23R 209685753 00643169624849 BB8S23R 209685754 00643169624849 BB8S23R 210141006 00643169624849 HY1W12R28 209821189 00643169620155 M273205G 210135065 00643169651258 M311110F 210007560 20643169409662 M311110F 210305334 20643169409662 M311110F 210646326 20643169409662 M311129K 210216215 00643169399280 M311129K 210637628 00643169399280 M311135D 210386285 00643169478183 M311136L 210100436 00643169515598 M311136L 210433599 00643169515598 M311151D 209903218 00643169475311 M321304B 210165927 20643169460694 M321709C 210129241 20643169636716 M322225D 210075636 00643169510203 M322225D 210175891 00643169510203 M322225D 210296690 00643169510203 M330119D 209872946 00643169583542 M331831E 210181103 00643169608412 M331831E 210322907 00643169608412 M334821J 210276579 00643169690967 M337503K 210300696 00643169490284 M338803C 210302285 00643169332539 M381004M 209998094 20643169299959 M381007B 209998093 20643169299942 M382206C 209998091 00643169480193 M421709C 210245944 00643169407367 M450202E 210093488 00643169648869 M450202E 210307287 00643169648869 M450311C 210143630 00643169617865 M450467K 210137624 00643169409781 M450467K 210188072 00643169409781 M450467K 210296689 00643169409781 M490753H 209918242 00643169472112 M490817B 210075633 00643169096271 M490817B 210513258 00643169096271 M491217D 210435629 00643169169197 M491546B 210006820 00643169415676 M491546B 210093491 00643169415676 M491547B 210254924 00643169415683 M491547B 210368459 00643169415683 M491908D 209930663 00643169655140 M494833B 209974536 00643169620087 M494833B 210099871 00643169620087 M494833C 210277621 00643169692589 M497549H 210112884 20643169588503 M497549H 210364073 20643169588503 M498408B 210093495 00643169640375 M499216B 209807154 00643169540866 M499709D 209974535 00643169348981 M612501C 210283502 00643169656901 1M66R1 210224823 00885074019369 1N16R19 209674468 00613994642028 1N16R19 209674469 00613994642028 1N16R19 209789389 00613994642028 1N16R19 210010537 00613994642028 1N16R19 210010538 00613994642028 1N16R19 210084995 00613994642028 1N16R19 210085738 00613994642028 1N16R19 210160297 00613994642028 1N16R19 210162743 00613994642028 1N16R19 210162744 00613994642028 2R88R3 209857551 00613994462732 2R88R3 210140927 00613994462732 5B54R3 209857561 00613994397959 5G80R6 209948268 00643169578531 5J39R30 209784926 00643169649156 5J39R30 209922891 00643169649156 5J39R30 210204096 00643169649156 6A30R1 209980203 00643169409538 6T40R6 209968093 00613994993083 6T40R6 209968189 00613994993083 6X37R6 210224830 00643169188983 7T88R 210300649 00643169276734 7Y17R1 209702296 00643169362840 8J59R 210046473 00643169485341 8J59R1 210219866 00643169673618 8J83R3 210224829 00643169673588 BB2N37R9 209646278 00643169534452 BB2N37R9 209857611 00643169534452 BB2N37R9 21007
Clasificación de riesgo
Class III
Área (FDA)
device
País
United States

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