Medtronic Custom Perfusion Tubing Pack — Class III medical device recall Z-1023-2016
Terminated recall by Medtronic Perfusion Systems, reported 2016-03-09, distributed in AK, AZ, CA, DE, FL, HI, IL, LA…. Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tubing Packs tha
| Recall number | Z-1023-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Perfusion Systems, Brooklyn Park, MN, United States |
| Recall initiated | 2016-02-04 |
| Classified | 2016-02-26 |
| Reported by FDA | 2016-03-09 |
| Terminated | 2016-11-07 |
| Distributed | AK, AZ, CA, DE, FL, HI, IL, LA, MA, MD, MN, MO, MS, NC, ND, NE, NJ, OH, OR, TN, TX, VA, WA, WI, WV |
| Countries outside the US | AU, BE, CA, CH, CZ, DE, DK, DO, FR, IL, JP, NL, RS, ZA |
| UPC / GTIN / UDI-DI | 00613994250964, 00613994294692, 00613994397959, 00613994462732, 00613994481900, 00613994481924, 00613994534545, 00613994534552, 00613994536624, 00613994596390, 00613994622358, 00613994642028, 00613994665973, 00613994667731, 00613994698445, 00613994720351, 00613994923264, 00613994993083, 00643169046634, 00643169051423, 00643169096271, 00643169098121, 00643169149816, 00643169158238, 00643169169197 and 185 more |
Product
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1023-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.