# FDA recall Z-2298-2023

> **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. CRMC MINOR IR PROCEDURE PK-LF, Model Numbers: DYNJ61099B, DYNJ61099C;    b. CRMC TUNNEL CATH TRAY-LF, Model Numbers: DYNJ61118C, DYNJ61118F;   c. CUSTOM ANGIO TRAY, Model Number: DYNJ41649G;   d. CUSTOM DUAL LUMEN 8.5 FRENCH CVC KIT, Model Number: ECVC2595;   e. CV MINOR CDS, Model Numbers: CDS984100U, CDS984100V;   f. CVC 16CM BUNDLE, Model Number: ECVC2225;   g. CVC 3L 7F 20CM VANTEX, Model Number: ECVC7265A;   h. CVC BUNDLE, Model Number: ECVC3235;   i. CVC BUNDLE 16CM, Model Number: ECVC2335;   j. CVC BUNDLE 20CM 3L, Model Number: ECVC5120B;   k. CVC BUNDLE 4L 20CM, Model Number: ECVC5095B;   l. CVC BUNDLE 7FR, 3L, 20CM, Model Numbers: ECVC6075, ECVC6460;   m. CVC BUNDLE KIT 16CM, Model Number: ECVC2240A;    n. CVC BUNDLE KIT 20CM, Model Number: ECVC2001;   o. CVC BUNDLE KIT 7F 3L 16CM, Model Number: ECVC7205A;   p. CVC BUNDLE KIT 7F 3L 20CM MULTIMED PI, Model Number: E

## 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-2298-2023
- **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-2298-2023

## Citation

> AI Analytics. FDA recall Z-2298-2023. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-2298-2023. Source: US FDA. Licensed CC0.

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