Product Wiki · Recalls · U.S. FDA — Device Enforcement

ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and… — recall Z-0744-2016

U.S. FDA — Device Enforcement · United States · 2015-12-21 · Class II

As described by U.S. FDA — Device Enforcement: 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 c

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0744-2016
Date of alert
2015-12-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Acist Medical Systems
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution - US including all states except DE, MT, RI, UT, & VT and Internationally to Belgium, France, Germany, Iceland, Ireland, Luxembourg, Netherlands, Reunion, United Kingdom, Australia, Austria, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Estonia, Gre
Reported risk: Reports related to ingress of air into the manifold.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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