Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Mo
Summary
The FDA issued a Class I for Convenience kits containing Medline Namic Angiographic Control Syringes with Rot by American Contract Systems Inc. Reason: Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection .
Details
Source
Device Recall
External ID
Z-1981-2026
Action Date
2026-05-13
Status
Ongoing
Category
device
Product Description
Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP ANCA80AQ
Lot/Code Info: ANCA80AP UDI-DI 191072232168 Lot 42-8146111 ANCA80AQ UDI-DI 191072236678 Lots 42-8207211 42-8267711 42-8311311 42-8337611 42-8353311 42-8379211 42-8407111 42-8510711 42-8575111 42-8611511 42-8718911 42-8718912 42-8722611 42-8805311 42-8820611 42-8870911
Quantity Affected: 7,311 kits
Reason for Recall
Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection or full disconnection between the syringe and manifold. Potential risk for biohazard exposure, blood loss, infection, or air embolism.
Distribution
US distribution to MN. No OUS distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-19
Company
Tiffin, OH
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 250 device recalls issued in the same week, part of 403 device-related FDA actions this month.
American Contract Systems Inc has 188 FDA actions in our database, including 188 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (American Contract Systems Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does American Contract Systems Inc have FDA actions?
American Contract Systems Inc has 188 FDA actions in our database, including 188 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1981-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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