DLP Pressure Disposable Pressure Display Sets Extends the pressure… — Class II medical device recall Z-2768-2017
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-2768-2017 |
|---|---|
| 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 | 20613994846604, 20613994846642 |
| Lot numbers | 2016020865, 2016030859, 2016031538, 2016040236, 2016040539, 2016040540, 2016040859, 2016041196, 2016050268, 2016050556, 2016051179, 2016051245, 201605C015, 201605C016, 201605C063, 201605C064, 201605C065, 201605C066, 201605C067, 201605C068, 201605C069, 2016060226, 2016060275, 2016060525, 2016060526, 2016060896, 2016060897, 2016060899, 2016061082, 2016061083, 2016061084, 2016061085, 2016061086, 2016061476, 2016061477, 2016061478, 2016061479, 2016061480, 2016061482, 2016070542 and 61 more |
| Model numbers | 61000, 62000 |
Product
DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure monitoring unit 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-2768-2017. 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.