Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes — Class II medical device recall Z-0361-2016
Terminated recall by Quest Medical, Inc., reported 2015-12-09, distributed nationwide. The products have been found to intermittently exhibit a seal failure during use.
| Recall number | Z-0361-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Quest Medical, Inc., Allen, TX, United States |
| Recall initiated | 2015-10-28 |
| Classified | 2015-12-02 |
| Reported by FDA | 2015-12-09 |
| Terminated | 2016-11-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CH, FR, IT, JP, KW, SA, ZA |
| Quantity | 18,761 units |
| Reason classes | packaging |
| Model numbers | 5001102-ASMPS, 5001102MPS, 7001102MPS |
Product
Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing; Model 5001102-AS MPS Delivery Set with 6 ft. delivery tubing; Model 7001102 MPS Low Volume Delivery Set for use with cardiopulmonary bypass equipment.
Reason for recall
The products have been found to intermittently exhibit a seal failure during use.
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-0361-2016. 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.