FDA Medical Device Recalls (openFDA)
Acist Medical Systems: ACIST Multi-Use Syringe Kit, Model A2000; SKU # : 014612; labeled as STERILE; Manufactured: Acist Medical Systems, Inc., 7450 Flying Cloud Drive, Suite 150, Eden Prairie, MN 55344, USA. Catalogue No: 800061-003. (The multiple use A20000 syringe kit is comprised of a terminally sterilized syringe barrel and a contrast spike assembly)
- Recall number
- Z-0359-2008
- Recalling firm
- Acist Medical Systems
- Product
- ACIST Multi-Use Syringe Kit, Model A2000; SKU # : 014612; labeled as STERILE; Manufactured: Acist Medical Systems, Inc., 7450 Flying Cloud Drive, Suite 150, Eden Prairie, MN 55344, USA. Catalogue No: 800061-003. (The multiple use A20000 syringe kit is comprised of a terminally sterilized syringe barrel and a contrast spike assembly)
- Status
- Terminated
- Initiated
- 2007-10-03
- Posted
- 2007-12-08
- Terminated
- 2008-10-06
- Reason
- Syringe Fracture: the syringe may be fractured, causing contrast to be sprayed from syringe fracture.
- Root cause
- Process design
- Action
- 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.
- Quantity
- 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, UT, VA, WA, WI, and WV.
- Lot, serial or model codes
- Lot Nos: 0037H, 0377K, 0647U, 0877H, 1077K, 3406J, 0037W, 0377L, 0657K, 0887G, 1087F, 3416H, 0197B, 0397T, 0667G, 0937L, 1087B, 3456J, 0197G, 0407F, 0677G, 0947F, 1137F, 3456L, 0227H, 0457G, 0817H, 0997P, 1157J, 3456P, 0227K, 0457H, 0857H, 0997T, 1217M, 3476F, 0247F, 0467G, 0867M, 1007K, 1227B, 0247G, 0647B, 0877B, 1017G, 3106G, 0307B, 0647F, 0877G, 1067F, and 3406H.
- 510(k) numbers
- ["K984231"]
- PMA numbers
- not on file
- Product code
- DXT
- Firm FEI
- 3001726808
- Firm city
- Eden Prairie
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28