Recall Z-0744-2016— Acist Medical Systems
Class II · Terminated
Class II FDA medical device recall by Acist Medical Systems, initiated 2015-12-21, terminated 2016-07-22. It names 2 FDA 510(k) clearances: K052744, K984231. 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: Reports related to ingress of air into the manifold..
- Recalling firm
- Acist Medical Systems
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-12-21
- Terminated
- 2016-07-22
- Firm location
- Eden Prairie, MN, United States
510(k) clearances named in this recall
2 on FDA's record- K052744 — C2000 AUTOMATED MANIFOLD KIT
- K984231 — ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.