ACIST Medical Systems — Class II medical device recall Z-0744-2016
Terminated recall by Acist Medical Systems, reported 2016-02-10, distributed in DE, MT, RI, UT, VT. Reports related to ingress of air into the manifold.
| Recall number | Z-0744-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Acist Medical Systems, Eden Prairie, MN, United States |
| Recall initiated | 2015-12-21 |
| Classified | 2016-02-02 |
| Reported by FDA | 2016-02-10 |
| Terminated | 2016-07-22 |
| Distributed | DE, MT, RI, UT, VT |
| Countries outside the US | AE, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CY, CZ, DE, EE, ES, FR, GB, GR, HK, HU, IE, IL, IR, IS, IT, JP, KR, KW, LT, LU, LV, MX, NL, NO, PA, PL, PT, RS, SA, SE, SI, SK, TH, TR, VE, ZA |
| Lot numbers | 08915J, 09015T, 09115H, 09315D, 09615N, 09615U, 09715X, 09815F, 10115D, 10215G, 10415D, 10415W, 10415Y, 10515P, 11015L, 11115K, 11215U, 11315M, 11715J, 11815G, 11915D, 12415J, 12615P, 13115M, 13415W, 13815G, 13915T, 14015P, 14115M, 14615D, 14615M, 15415G, 15715D, 16115H, 16315L, 16515E, 16615Z, 16815J, 16915N, 17115F and 50 more |
Product
ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) Automated Manifold Kits, Sterile R, Rx Only, Made in Mexico. The manifold body is identical in the BT2000 and CPT2000 kits. The BT2000 and CPT2000 kits facilitate connection to, and delivery of, either contrast or saline into the patient via a coronary catheter (not provided by ACIST). To be used for the controlled infusion of radiopaque contrast media for angiographic procedures
Reason for recall
Reports related to ingress of air into the manifold.
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-0744-2016. 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.