FDA-Device2026-07-01Class IPROCESSING DEFECT

Medline Convenience Kits with anesthesia injectables recalled for supplier quality issues

OTHERNationwide distributionMedical devices

What this means

Medline Convenience Kits used in cardiovascular anesthesia room setups contain anesthesia injectables (Lidocaine and Bupivacaine) that were recalled due to quality problems found during an FDA inspection of the supplier. The affected kits are used in hospital operating rooms.

  • Check your facility's inventory for the affected Medline kit model numbers: DYNJ905503F or DYNJ905503G
  • Do not use kits matching the recalled lot numbers listed in the FDA notice
  • Contact Medline Industries for instructions on return or replacement
  • Review your records for any kits already used and report to your quality assurance team
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The agency's original wording
Hazard

The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.

Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide.
Affected count
227 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROOM SET UP; 2) DYNJ905503G, Model Number: CV ANESTHESIA - ROOM SET UP

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2452-2026

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