ACIST Angiographic Injection System Recall for Air Ingress
Acist Medical Systems is recalling 6,640 units of BT2000 Automated Manifold Kits due to air ingress into the manifold body.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect (air ingress) that halts the procedure, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Acist Medical Systems is issuing a voluntary recall for 6,640 units of BT2000 Automated Manifold Kits. The recall covers specific lots with codes 23884007, 23884008, and 23884009. These kits are components of the ACIST Angiographic Injection System, which is intended for the controlled infusion of radiopaque contrast media during angiographic procedures.
The recall was initiated after the manufacturer received field reports indicating air ingress into the manifold body. This issue is detected by the Air Column Detect Sensor, which halts the injection process. To proceed with the procedure, replacement of the BT2000 Automated Manifold Kit is typically necessary.
The affected units were distributed nationwide, including in the states of AL, AK, AZ, AR, CA, CO, CT, DC, GA, HI, ID, IL, IN, IA, KS, KY, MD, MI, MN, MS, MO, NV, NH, NJ, NM, NY, NC, OR, OK, OH, PA, TN, TX, VA, and WA. Healthcare facilities should check their inventory for the specific lot codes listed and contact the manufacturer for replacement instructions.
The recalled product
- Product
- ACIST Medical Systems Inc. The ACIST Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
- Manufacturer
- Acist Medical Systems
- Affected units
- 6,640
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 23884007
- 23884008
- 23884009
Distribution
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