FDA Recall of Arrowg+ard Blue Plus Four-Lumen CVC Kits
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ARROW INTERNATIONAL, LLC is recalling certain Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC Kits due to issues with the liquid adhesive manufacturing.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 8, 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 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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What Happened
ARROW INTERNATIONAL, LLC is recalling the Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC Kit because the liquid adhesive was incorrectly manufactured.
Which Products Are Affected
The affected products include:
- Product Code: ASK-45854-PUPM1, UDI code: (01)10801902159578(17)270531(11)251205(10)33F25M0011, Batch Number: 33F25M0011
- Product Code: ASK-45703-MGH, UDI code: (01)10801902223675(17)261231(11)251209(10)33F25L0143, Batch Number: 33F25L0143
- Product Code: ASK-42854-MGH, UDI code: (01)10801902223668(17)261231(11)251210(10)33F25L0144, Batch Number: 33F25L0144
- Product Code: ASK-45854-MGH, UDI code: (01)10801902223699(17)261231(11)251209(10)33F25L0145, Batch Number: 33F25L0145 Quantity: 5 units. Distributed in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA. Official recall number: Z-1915-2026.
What You Should Do
Consumers should contact ARROW INTERNATIONAL, LLC at their address: 3015 Carrington Mill Blvd, Morrisville, NC 27560-5437 for instructions on returns or refunds, as the recall was initiated via letter.
Why This Matters
This recall involves medical devices that may affect patient safety due to potential manufacturing defects in the adhesive.
Source
Attributed to FDA, recall number Z-1915-2026.
Original source: FDA Official Notice ↗
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