Z-1872-2009

ACIST Automated Manifold Kit , REF Model BT2000, SKU # 014613, Sterile R, Made in Mexico, Manufacturer; ACIST...

Name: Z-1872-2009 ACIST Automated Manifold Kit , REF Model BT2000, SKU # 014613, Sterile R, Made in Mexico, Manufacturer; ACIST...
Creator: Acist Medical Systems
Published: 2009-05-11
License: https://open.fda.gov/license/

Acist Medical Systems, Inc. / initiated 2009-05-11 / Terminated / root cause: manufacturing process

FDA source

Acist Medical Systems began a recall of ACIST Automated Manifold Kit , REF Model BT2000, SKU # 014613, Sterile R, Made in Mexico, Manufacturer; ACIST LMedical Systems Inc, 7605 Fuller Road, Eden... on 2009-05-11. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1872-2009
Status: Terminated
Initiated: 2009-05-11
Posted: 2009-08-30
Terminated: 2012-02-04
Recalling firm: Acist Medical Systems, Inc.
Product: 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.
Product code: DXT Injector And Syringe, Angiographic
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 62, 280 (57,110 US, 5130 Canada, 40 Hong Kong)
Distribution: 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
Product codes and lots: Lot numbers: 2968J 3088N 3168H 3178H 2968K 3088P 3168J 3308U 2968L 3088T 3168K 3468W

Product code DXT

K040298Class IIAcist Antiographic Injection System Contrast Management Disposable KitsAcist Medical Systems, Inc. / cleared 2004-03-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)