DLP Extension Line Adapters 20 in length Used to extend cardioplegia… — Class II medical device recall Z-2764-2017
Terminated recall by Medtronic Perfusion Systems, reported 2017-08-02, distributed nationwide. Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven diff
| Recall number | Z-2764-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Perfusion Systems, Brooklyn Park, MN, United States |
| Recall initiated | 2017-06-22 |
| Classified | 2017-07-25 |
| Reported by FDA | 2017-08-02 |
| Terminated | 2020-07-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BG, CA, DE, DK, ES, FR, GB, HR, HU, IE, IL, IT, JP, KW, LB, NG, NL, NO, NZ, PL, RO, SI, SV, TH, TR |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 20613994918554 |
| Lot numbers | 2016020769, 2016030796, 2016040778, 2016060872, 2016061425, 2016070500, 2016081190, 2016090516, 2016091016, 2016110504, 2016120414, 2017010236, 2017011281, 2017030506 |
| Model numbers | 11001G |
Product
DLP Extension Line Adapters 20 in length Used to extend cardioplegia line during cardiopulmonary bypass surgery
Reason for recall
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
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-2764-2017. 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.