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fda_recall · device_recall · high

Medline Industries, LP — Class II recall: Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N

Event date
2026-09-23 00:00:00Z
Observed
2026-09-29 04:20:31Z
Source ID
Z-3137-2026
Payload hash
03ef359c69b1b016aa9a4e2d…

Summary

The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product cannot be assured. If a compromised pouch seal is not identified prior to use and the cannula is used, there is a potential risk of infection or other… Status: Ongoing.

Frequently asked questions

Has Medline Industries, LP had other FDA enforcement actions?
Yes. Argus HQ has recorded 353 total FDA actions tied to Medline Industries, LP: 0 warning letters, 353 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?
This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-09-23; Argus observed and indexed it on 2026-09-29.
Where can I verify this record directly with FDA?
The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

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). Medline Industries, LP — Class II recall: Medline Convenience Kit:  OPEN HEART A PACK, Product Number DYNJ43008N. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-medline-industries-lp-z-3137-2026
MLA
"Medline Industries, LP — Class II recall: Medline Convenience Kit:  OPEN HEART A PACK, Product Number DYNJ43008N." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-medline-industries-lp-z-3137-2026.
Chicago
Argus HQ Research. "Medline Industries, LP — Class II recall: Medline Convenience Kit:  OPEN HEART A PACK, Product Number DYNJ43008N." Digital Empire Holdings LLC. Accessed September 29, 2026. https://argushq.ai/events/fda-recall-medline-industries-lp-z-3137-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_medline_industries_lp_z_3137_2026_2026,
  title = {Medline Industries, LP — Class II recall: Medline Convenience Kit:  OPEN HEART A PACK, Product Number DYNJ43008N},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-medline-industries-lp-z-3137-2026},
  note = {Accessed: September 29, 2026}
}

Informational only. Not legal, financial, or medical advice.