# FDA recall Z-2323-2023

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2023-05-15.

## Product

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:     a. ADULT EPIV INSERTION TRAY, Model Number: DYNDA2482;     b. ARTERIAL LINE START KIT, Model Number: ART920;     c. CENTRAL LINE INSERTION TRAY, Model Number: DT19810;    d. ECMO INSERTION BUNDLE W/O CANNULA, Model Number: CVI4915;       e. FLOOR ULTRASOUND GUIDED IV SECUREMENT, Model Number: IVS3770;       f. IV SECUREMENT KIT, Model Number: DYNDV2407A;       g. MIDLINE BUNDLE 4FR SL, Model Number: MID0005;       h. MIDLINE INSERTION TRAY, Model Number: CVI4340;       i. MIDLINE KIT 4F SL MAX BARRIER STD, Model Number: MIDST04011;       j. MIDLINE KIT 4F SL MB, Model Number: MID0001;       k. MIDLINE KIT 4F SL PL MAX BARR, Model Number: DYNJ80141MB, MID0003;       l. MIDLINE KIT 4F SL PL MB, Model Number: PICC0009A;       m. MIDLINE KIT 5F DL PL MAX BARR, Model Number: DYNJ80152MB;       n. NEONATAL PICC INSERTION TRAY, Model Number: DYNDA2509A, MNS8765;       o. NEONATAL P

## Reason for recall

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

## Key facts

- **Recall number:** Z-2323-2023
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-15
- **Report date:** 2023-08-09

- **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-2323-2023

## Citation

> AI Analytics. FDA recall Z-2323-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2323-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*