# FDA recall Z-1391-2026

> **Medline Industries, LP** · Class II · device recall initiated 2026-01-07.

## Product

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 Numb

## Reason for recall

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.

## Distribution

Worldwide distribution - US Nationwide.

## Key facts

- **Recall number:** Z-1391-2026
- **Recalling firm:** Medline Industries, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-01-07
- **Report date:** 2026-02-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-1391-2026. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1391-2026. Source: US FDA. Licensed CC0.

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