Recall Z-1872-2009 ยท DXT Injector And Syringe, Angiographic
Acist Medical Systems
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 A
| Date | Aug 30, 2009 (initiated May 11, 2009) |
| Status | Terminated |
| Reason | 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 | 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040298 | ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS Acist Medical Systems, Inc., Mar 15, 2004 |