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FDA-Device2026-02-25Class IIPACKAGING DEFECT

Medline surgical and central line kits recalled for sterilization equipment calibration issues

Medline
OTHERNationwide distribution

Check Medline surgical kits for sterilization concerns

Medline identified calibration problems with sterilization equipment used to process over 24 models of surgical procedure kits and central line trays. Although the kits went through sterilization cycles, the equipment calibration issues may have affected their sterility. No injuries have been reported.

  • Check your inventory for Medline surgical kits and trays matching the recalled model numbers and lot numbers listed on the FDA website
  • Do not use recalled kits until you verify they are safe
  • Contact Medline or your facility's supply chain for instructions on returning or replacing affected products
  • Report any adverse events to Medline customer service or the FDA MedWatch program
Hazard

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Sold states
Worldwide distribution - US Nationwide.
Affected count
5346 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline Convenience Kits: 1) PICC LINE TRAY, Model Number: 00-401993O; 2) CODE CART ADULT 4 CENTRAL LINE, Model Number: ACC010268B; 3) CODE CART ADULT 4 CENTRAL LINE, Model Number: ACC010268C; 4) TRAY 6 CENTRAL LINE A, Model Number: ACC010487; 5) PEDS PICC INSERTION TRAY, Model Number: CVI3650; 6) LINE ATTIRE KIT, Model Number: DYKM2170; 7) KIT SURG ONC LAP DIAG/PORT INS, Model Number: DYKMBNDL153C; 8) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43A; 9) KIT SURG ONC PORT INSERTION, Model Number: DYKMBNDL43C; 10) VEIN PROCEDURE KIT, Model Number: DYNDA2076B; 11) VEIN PROCEDURE KIT, Model Number: DYNDA2076D; 12) VEIN PROCEDURE KIT, Model Number: DYNDA2076F; 13) PLACENTA KIT, Model Number: DYNDA2322B; 14) NICU CENTRAL LINE TRAY, Model Number: DYNDC2407A; 15) NICU CENTRAL LINE TRAY, Model Number: DYNDC2407B; 16) PICC LINE TRAY, Model Number: DYNJ40500A; 17) VENOUS ACCESS PACK, Model Number: DYNJ42694C; 18) AV FISTULA CREATION PACK-LF, Model Number: DYNJ53427B; 19) PICC LINE, Model Number: DYNJ55546D; 20) PICC TRAY, Model Number: DYNJ63199A; 21) PICC KIT 4F SL PL MAX BARRIER, Model Number: DYNJ70141MB; 22) PICC KIT 5F DL PL MB, Model Number: DYNJ70152MB; 23) VEIN PACK, Model Number: DYNJ84239; 24) PICC INSERTION TRAY W/O CATH, Model Number: PICCNC0004

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1391-2026

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