Acist Medical Systems Recalls BT2000 and CPT2000 Automated Manifold Kits
Acist Medical Systems is recalling BT2000 and CPT2000 Automated Manifold Kits due to reports of air ingress into the manifold.
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 is classified as FDA Class II, and the hazard involves air ingress into a medical device used for patient infusion, which poses a risk of harm even though specific injuries are not detailed in the source text.
Plain-English summary
Acist Medical Systems is recalling BT2000 (SKU 014613) and CPT2000 (SKU 14623) Automated Manifold Kits. These sterile, prescription-only medical devices are used to facilitate the connection and delivery of contrast or saline into patients via a coronary catheter during angiographic procedures.
The recall was initiated due to reports related to the ingress of air into the manifold. The affected products were distributed worldwide, including in the United States (excluding Delaware, Montana, Rhode Island, Utah, and Vermont) and in numerous international markets.
Healthcare facilities and consumers should stop using the affected kits and contact Acist Medical Systems for further instructions. The recall covers 48,614 cartons, or 486,140 units, across multiple lot numbers.
The recalled product
- Product
- ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) Automated Manifold Kits, Sterile R, Rx Only, Made in Mexico. The manifold body is identical in the BT2000 and CPT2000 kits. The BT2000 and CPT2000 kits facilitate connection to, and d
- Manufacturer
- Acist Medical Systems
- Category
- Medical Device — Cardiovascular
- Hazard
Distribution
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