ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) Automated Manifold Kits, Ster

FDA device recall Z-0744-2016 · posted 2016-02-02 · Terminated

Recall details

Recalling firm

Acist Medical Systems

Reason for recall

Reports related to ingress of air into the manifold.

Action taken

Acist sent an Urgent Medical Device Recall letter dated December 21, 2015, via e-mail to all affected consignees. The letter was addressed to Distribution Partner or Cardiac Cath Lab / Material Manager in the USA. In Europe, the letter was addresses to Purchasing Department. The letter described the problem and the product involved in the recall. Advised consignees to return affected units and to complete and return the Medical Device Recall Form. Distributors were further advised to send the recall letter to their customers. For questions or concerns, contact in US, ACIST Customer Service 1-888-670-7701 or your ACIST Sales Representative. Europe Direct contact ACIST Europe Customer Service +44 (0) 845 548 12 80 or contact your ACIST Sales Representative, Europe Indirect contact ACIST Europe Customer Service +31 45 750 70 25 or contact your Distributor. Distributors contact: ACIST Europe BV, Office: +31 (0)45 750 7015, Mobile: +31 (0)6 233 648 46.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

DXT

Quantity affected

48,614 cartons or 486,140 units

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, Austra

Date initiated

2015-12-21

Date posted

2016-02-02

Date terminated

2016-07-22

Location

Eden Prairie, MN

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