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FDA-Device2026-07-01Class IPROCESSING DEFECT

Medline open heart surgical kits recalled for anesthetic quality issues

Medline
OTHERNationwide distributiondevice

Medline open heart kits recalled for anesthetic quality issues

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.
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.

Who it affects
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

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