# FDA recall Z-2324-2023

> **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. CENTRAL LINE INSERT KIT W/O CA, Model Number: CVI3755;       b. CENTRAL LINE KIT, Model Number: DYNDC2582, DYNDC2582A;     c. CENTRAL LINE PACK-COMPANION, Model Number: DYNJ47215D;    d. CENTRAL LINE TRAY, Model Number: DYNJ42902B;       e. CENTRAL LINE UNIVERSAL INSERTION, Model Number: CVI3780;       f. CLOSURE PACK, Model Number: DYNJ83054A;       g. DBD-PICC LINEPACK PCLUI642-LF, Model Number: DYNJ47717A;       h. ER CENTRAL LINE KIT, Model Number: P155508B, P155508C;       i. HEMODIALYSIS CENTRAL LINE, Model Number: DYNJ63347;       j. LINE KIT, Model Number: DYNJ47987A;       k. PEDIATRIC CENTRAL LINE KIT, Model Number: DYNJ38885B;       l. PK CUST CENTRAL LINE PACK, Model Number: DYNJ60586;       m. TRAY LACERATION, Model Number: DYNDL1134A;       n. TUNNEL LINE PACK, Model Number: DYNJ67990;       o. ULTRASOUND GUIDED IV/MIDLINE K, Model Number: DYNDV2385;

## 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-2324-2023
- **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-2324-2023

## Citation

> AI Analytics. FDA recall Z-2324-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2324-2023. Source: US FDA. Licensed CC0.

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