FDA-Device2026-07-01Class IPROCESSING DEFECT

Medline open heart surgical kits recalled for anesthetic quality issues

OTHERNationwide distributionMedical devices

What this means

Medline Convenience Kits used in cardiac surgery contain anesthetic medications (Lidocaine and Bupivacaine) that were recalled by their supplier due to quality concerns found during an FDA inspection. About 6,775 affected kits have been distributed to hospitals and surgical centers.

Contact your hospital or surgical facility immediately if you have received any of these kits.
Do not use affected kits in procedures until cleared by your facility.
Check the model numbers and lot numbers against the FDA recall list to determine if your kits are affected.
Follow your facility's protocol for quarantining and returning recalled surgical supplies.

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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

6775 units

Manufactured in

3 Lakes Dr, N/A, Northfield, IL, United States

Products

Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840144Q; 2) OPEN HEART, Model Number: CDS840150W; 3) OPEN HEART ADULT, Model Number: CDS840396AA; 4) CABG A CDS, Model Number: CDS982269N; 5) OPEN HEART ANESTHESIA PACK, Model Number: CDS983849G; 6) OPEN HEART ACCESSORY CDS, Model Number: CDS984289L; 7) OPEN HEART A, Model Number: CDS985105Q; 8) OPEN HEART PART 2, Model Number: DYNJ901075R; 9) VPH OPEN HEART, Model Number: DYNJ902664L; 10) HEART A, Model Number: DYNJ903465I; 11) HEART, Model Number: DYNJ903822F; 12) OPEN HEART BASIC B, Model Number: DYNJ904311F; 13) SM OPEN HEART PACK A&B, Model Number: DYNJ904749J; 14) OPEN HEART ANESTHESIA ICC-B, Model Number: DYNJ905567B; 15) SILVER CROSS OPEN HEART, Model Number: DYNJ906102K; 16) ANESTHESIA OPEN HEART, Model Number: DYNJ906225I; 17) OPEN HEART COMBO, Model Number: DYNJ907400F; 18) CARDIAC CABG B, Model Number: DYNJ908121C; 19) FS OPEN HEART, Model Number: DYNJ908308A; 20) OPEN HEART SUPPLEMENT, Model Number: DYNJ909116D; 21) MEM CARDIAC, Model Number: DYNJ9622573AP; 22) OPEN HEART A & B PACK, Model Number: DYNJ9718008AT

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2453-2026

More Medline recalls

FDA-Device2026-09-09
Medline Convenience Kits recalled for potential sterility breach in antiseptic applicators
FDA-Device2026-09-09
Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for contamination risk
FDA-Device2026-09-09
Medline Convenience Kits recalled for sterility packaging breach risk
FDA-Device2026-09-09
Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
FDA-Device2026-09-09
Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk

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