ACIST Automated Manifold Kit , REF Model BT2000, SKU # 014613, Sterile R, Made in Mexico, Manufacturer; ACIST LMedical S
FDA device recall Z-1872-2009 · posted 2009-08-30 · Terminated
Recall details
- Recalling firm
- Acist Medical Systems
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- DXT
- Quantity affected
- 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
- Date initiated
- 2009-05-11
- Date posted
- 2009-08-30
- Date terminated
- 2012-02-04
- Location
- Eden Prairie, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS (K040298) | Acist Medical Systems, Inc. | 2004-03-15 |