Z-0359-2008

ACIST Multi-Use Syringe Kit, Model A2000; SKU # : 014612; labeled as STERILE; Manufactured: Acist Medical...

Name: Z-0359-2008 ACIST Multi-Use Syringe Kit, Model A2000; SKU # : 014612; labeled as STERILE; Manufactured: Acist Medical...
Creator: Acist Medical Systems
Published: 2007-10-03
License: https://open.fda.gov/license/

Acist Medical Systems, Inc. / initiated 2007-10-03 / Terminated / root cause: manufacturing process

FDA source

Acist Medical Systems began a recall of ACIST Multi-Use Syringe Kit, Model A2000; SKU # : 014612; labeled as STERILE; Manufactured: Acist Medical Systems, Inc., 7450 Flying Cloud Drive, Suite 150... on 2007-10-03. The reason FDA records is "Syringe Fracture: the syringe may be fractured, causing contrast to be sprayed from syringe fracture". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0359-2008
Status: Terminated
Initiated: 2007-10-03
Posted: 2007-12-08
Terminated: 2008-10-06
Recalling firm: Acist Medical Systems, Inc.
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)
Product code: DXT Injector And Syringe, Angiographic
Reason for recall: Syringe Fracture: the syringe may be fractured, causing contrast to be sprayed from syringe fracture.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: 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.

Product code DXT

K984231Class IIAngiographic Contrast Management System, Model Part a and Part BInvasatec / cleared 2000-05-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)