Recall of MAC Two-Lumen Central Venous Access Kit
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, cpsc, Devices.
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 ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,134 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 7, 2026.
Frequently Asked Questions
Common questions about this FDA recall.