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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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)
Brand
Acist Medical Systems
Lot Codes / Batch Numbers
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.
Products Sold
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.
Acist Medical Systems is recalling ACIST Multi-Use Syringe Kit, Model A2000; SKU # : 014612; labeled as STERILE; Manufactured: Acist Me due to Syringe Fracture: the syringe may be fractured, causing contrast to be sprayed from syringe fracture.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Syringe Fracture: the syringe may be fractured, causing contrast to be sprayed from syringe fracture.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026