{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Brooklyn Park", "state": "MN", "country": "United States", "classification": "Class III", "openfda": {}, "product_type": "Devices", "event_id": "73261", "recalling_firm": "Medtronic Perfusion Systems", "address_1": "7611 Northland Dr N", "address_2": "N/A", "postal_code": "55428-1088", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "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.", "recall_number": "Z-1023-2016", "product_description": "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", "product_quantity": "9890 (7773 US, 2117 OUS)", "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.", "recall_initiation_date": "20160204", "center_classification_date": "20160226", "termination_date": "20161107", "report_date": "20160309", "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 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