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 us
Check against the official notice below — it lists the full affected range.
Medtronic is notifying customers about specific lots of Medtronic Perfusion Tubing Packs that contain potentially affected cuvettes manufactured by Terumo Cardiovascular Systems. Terumo CVS issued an Urgent Safety Alert regarding the CD I¿ H/S Cuvette, which is packaged into the Medtronic tubing packs and sold only as part of these packs. A total of 9,890 units were distributed worldwide, with 7,773 units in the US across multiple states and 2,117 units distributed internationally to countries including Australia, Belgium, Canada, France, Germany, Japan, and others.
The affected product includes multiple catalog numbers and lot numbers detailed in the recall record. The source document does not specify a remedy for consumers who have received these products.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: 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. Quantity: 9890 (7773 US, 2117 OUS) Lot/code info: 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 M49154
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.