# FDA recall Z-2297-2023

> **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. (13) STC IVC FILTER/ANGIOGRAM, Model Number: DYNJ908249A;    b. 16CM 3L 7FR CVC INSERTION BUNDLE, Model Numbers: ECVC7410A;   c. 16CM 7F 3L CVC MAX BARRIER INSERTION, Model Number: ECVC2205A;   d. 16CM 7F CVC INSERTION TRAY, Model Number: ECVC8095;   e. 16CM CVC BUNDLE W/MICROPUNCTURE KIT, Model Number: ECVC5010A;   f. 16CM CVC INSERTION KIT, Model Number: ECVC6800A;   g. 16CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number: ECVC2555;   h. 16CM TRIPLE LUMEN CVC INSERT BUNDLE, Model Number: ECVC4125;   i. 20CM 3L 7FR CVC INSERTION BUNDLE, Model Number: ECVC5135B;   j. 20CM 3L CVC INSERTION TRAY, Model Number: ECVC7325;   k. 20CM 7F 3L CVC MAX BARRIER INSERTION, Model Number: ECVC1970B;   l. 20CM 7F CVC INSERTION TRAY, Model Number: ECVC4335;   m. 20CM CVC TRIPLE LUMEN SAFETY BUNDLE, Model Number: ECVC7160;   n. 20CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number: ECVC2560;   o. 2

## 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-2297-2023
- **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-2297-2023

## Citation

> AI Analytics. FDA recall Z-2297-2023. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/Z-2297-2023. Source: US FDA. Licensed CC0.

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