Recall of MAC Two-Lumen Central Venous Access Kit
ARROW INTERNATIONAL, LLC is voluntarily recalling 90 units of the MAC Two-Lumen Central Venous Access Kit due to incorrectly manufactured liquid adhesive, affecting devices distributed in specific U.S. states.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 7, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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Recall Article
What Happened
ARROW INTERNATIONAL, LLC is initiating a voluntary recall of the MAC Two-Lumen Central Venous Access Kit because they received a notice from a supplier that the liquid adhesive was incorrectly manufactured.
Which Products Are Affected
The affected product is the MAC Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, REF ASK-11142-LC2, with UDI code (01)10801902206807(17)270531(11)251211(10)33F25M0670 and Batch Number 33F25M0670. Approximately 90 units are affected, distributed in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.
What You Should Do
Consumers who have the affected product should contact ARROW INTERNATIONAL, LLC at their address: 3015 Carrington Mill Blvd, Morrisville, NC 27560-5437, for instructions on returning the product, as the recall was initiated via letter.
Why This Matters
This recall affects medical devices used for short-term venous access, which could impact patient safety if the adhesive is faulty. It highlights the importance of quality control in medical product manufacturing.
Source
FDA Recall Number: Z-1916-2026
Original source: FDA Official Notice ↗
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