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Terminated

ACIST Automated Manifold Kit , REF Model BT2000, SKU # 014613, Sterile R, Made in Mexico, Manufacturer; ACIST LMedical Systems Inc, 7605 Fuller Road, Eden Prairie, MN .55344. The automated manifold kit is comprised of an injection manifold, a pressure transducer cartridge, a check valve, tubing (low, high and peristaltic pump), and a saline spike. This kit is designed for exclusive use with the ACIST CMS2000, E2000 Voyager and CVi models of Angiographic Contrast Delivery Systems. This kit is for single use.

FDA Recall Z-1872-2009 · Posted 2009-08-30

Recalling FirmAcist Medical Systems
Recall StatusTerminated
Product CodeDXT
Date Initiated2009-05-11
Date Terminated2012-02-04
Product Quantity62, 280 (57,110 US, 5130 Canada, 40 Hong Kong)

Reason for Recall

ACIST Medical Systems initiated a recall due to an increase in the incidence of field reports related to a bulge on the side and/or leaks in the bond of the 2.5 high-pressure tubing of BT2000 kits during a procedure which can result in unsatisfactory performance of the ACIST BT2000 Automated Manifold Kit.

Firm Action

Consignees were sent on 5/11/09 a ACIST Medical Systems "Urgent: Medical Device Recall" letter dated May 11, 2009. The letter described the problem and the product. It advised consignees to discontinue the use or further distribution of the recall product and to return the inventory and the enclosed "Medical Device Recall Form". Please use the enclosed form with firms address: 7905 Fuller Rd, Eden Prairie, MD 55344. Additional questions please contact the firm at 1-877-272-2269, option 1.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution including the states of AL, AZ, AR, CA, CO, CT, DC, FL, GA, HI, IL, ID, IN, IA, KS, KY, LA, MD, MI, MN, MS, MO, NE,NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT VA, WA, and WI.The countries of CANADA and HONG KONG

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040298ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITSAcist Medical Systems, Inc. · 2004-03-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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