Has ARROW INTERNATIONAL, LLC had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 47 total FDA actions tied to ARROW INTERNATIONAL, LLC, including 47 recalls and 0 warning letters.

FDA Class II Recall: ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE… by ARROW INTERNATIONAL, LLC

Key facts

Recalling firm	ARROW INTERNATIONAL, LLC
Manufacturer	Not disclosed in the FDA record.
Brand name	Not disclosed in the FDA record.
Product description	ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140 REF ASK-45703-MGH UDI code: (01)10801902223675(17)261231(11)251209(10)33F25L0143 REF ASK-42854-MGH UDI code: (01)10801902223668(17)261231(11)251210(10)33F25L0144 REF ASK-45854-MGH UDI code: (01)10801902223699(17)261231(11)251209(10)33F25L0145 The Arrowg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (> 30 days). Clinical effectiveness of the Arrowg+ard Blue Plus catheter in preventing CRBSIs compared to the original Arrowg+ard Blue¿ catheter has not been studied.
Classification	Class II
Recall number	Z-1914-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

In short: ARROW INTERNATIONAL, LLC recalled ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140 REF ASK-45703-MGH UDI code: (01)10801902223675(17)261231(11)251209(10)33F25L0143 REF ASK-42854-MGH (additional items listed in FDA's full record) on 2026-04-29. FDA classified this action as a Class II recall (recall number Z-1914-2026). Reason for recall: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured. Recall status: Ongoing. This is a device-category FDA recall record.

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is ARROW INTERNATIONAL, LLC and the affected product is described in FDA's record as: ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140 REF ASK-45703-MGH UDI code: (01)10801902223675(17)261231(11)251209(10)33F25L0143 REF ASK-42854-MGH (additional items listed in FDA's full record). FDA's stated reason for the recall is: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured. The recall is tracked under FDA recall number Z-1914-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140 REF ASK-45703-MGH UDI code: (01)10801902223675(17)261231(11)251209(10)33F25L0143 REF ASK-42854-MGH (additional items listed in FDA's full record) -- and the recall number Z-1914-2026. If it matches, stop using or distributing it and contact ARROW INTERNATIONAL, LLC or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

ARROW INTERNATIONAL, LLC’s FDA history

Argus HQ has recorded 47 total FDA actions tied to ARROW INTERNATIONAL, LLC: 0 warning letters, 47 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

How serious is this recall?: FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.
What should someone who has this product do?: Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140 REF ASK-45703-MGH UDI code: (01)10801902223675(17)261231(11)251209(10)33F25L0143 REF ASK-42854-MGH (additional items listed in FDA's full record)) and recall number Z-1914-2026, then follow ARROW INTERNATIONAL, LLC's recall instructions.
Has ARROW INTERNATIONAL, LLC had other FDA recalls or enforcement actions?: Yes. Argus HQ has recorded 47 total FDA actions tied to ARROW INTERNATIONAL, LLC, including 47 recalls and 0 warning letters.
What is the FDA recall number for this event?: FDA recall number Z-1914-2026.

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Full FDA history for ARROW INTERNATIONAL, LLC

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). FDA Class II Recall: ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE… by ARROW INTERNATIONAL, LLC — Recall Details. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/recall/fda-recall-arrow-international-llc-z-1914-2026

MLA

"FDA Class II Recall: ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE… by ARROW INTERNATIONAL, LLC — Recall Details." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/recall/fda-recall-arrow-international-llc-z-1914-2026.

Chicago

Argus HQ Research. "FDA Class II Recall: ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE… by ARROW INTERNATIONAL, LLC — Recall Details." Digital Empire Holdings LLC. Accessed July 24, 2026. https://argushq.ai/recall/fda-recall-arrow-international-llc-z-1914-2026.

BibTeX

@misc{argushq_argushq_ai_recall_fda_recall_arrow_international_llc_z_1914_2026_2026,
  title = {FDA Class II Recall: ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE… by ARROW INTERNATIONAL, LLC — Recall Details},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/recall/fda-recall-arrow-international-llc-z-1914-2026},
  note = {Accessed: July 24, 2026}
}

Source: FDA.gov — Recalls ↗