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 f
Hazard
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.
What You Should Do
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.
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Products
- Brand
- Acist Medical Systems
- UPC
- Lot numbers: 2968J 3088N 3168H 3178H 2968K 3088P 3168J 3308U 2968L 3088T 3168K 3468W
Units Affected
62, 280 (57,110 US, 5130 Canada, 40 Hong Kong)