ACIST Multi-Use Syringe Kit, Model A2000; SKU # : 014612; labeled as STERILE; Manufactured: Acist Medical Systems, Inc.,
FDA device recall Z-0359-2008 · posted 2007-12-08 · Terminated
Recall details
- Recalling firm
- Acist Medical Systems
- Reason for recall
- Syringe Fracture: the syringe may be fractured, causing contrast to be sprayed from syringe fracture.
- Action taken
- The Urgent Medical Device Recall letter was sent by certified mail to all U.S. base customers on 10/3,4/07. Customers were advised to stop distribution of the product and immediately cease use of the product. Recalled product is to be returned using the FedEx Airbill that was enclosed with the recall letter. Customers were to complete the enclosed "Device Recall Response" form even if they did not have any impacted kits in inventory.
- Root cause
- Process design
- Status
- Terminated
- Product code
- DXT
- Quantity affected
- 177,050 Kits
- Distribution
- Nationwide Distribution - including states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX
- Date initiated
- 2007-10-03
- Date posted
- 2007-12-08
- Date terminated
- 2008-10-06
- Location
- Eden Prairie, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B (K984231) | Invasatec | 2000-05-31 |