# FDA recall Z-2319-2023

> **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. 7F, 20CM TRIPLE LUMEN CVC BUNDLE, Model Number: ECVC4740;     b. A V GRAFT, Model Number: DYNJ36212C;   c. AAA, Model Number: DYNJ905651, DYNJ905651A, DYNJ905651B;     d. AAA PACK, Model Number: DYNJ44918C;     e. AAA PACK - TEAM 3, Model Number: DYNJ44847G;     f. ABLATION PACK, Model Number: DYNJ62540, DYNJ64068;     g. ABLATION/DRAINAGE PACK, Model Number: DYNJ53658A;     h. ACCESS KIT, Model Number: DYNDH1159A;     i. ACCESS PACK, Model Number: DYNJ69017;     j. ACCESSORY KIT, Model Number: DYNJ901348D;     k. ADULT CORONARY PACK, Model Number: DYNJV0275F;     l. ADULT CVC MAX BARRIER KIT-LF, Model Number: DYNJ38714B;     m. ALL PURPOSE TRAY FOAKS, Model Number: DYNJ63576, DYNJ63576A;     n. AMINO KIT; Model Number: DYNDH1649;     o. AMNIOCENTESIS TRAY, Model Number: DYNDH1420;     p. ANGIO STANDARD PACK-LF, Model Number: DYNJ0370436Q;     q. ANGIO TRAY, Model Number: D

## 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-2319-2023
- **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-2319-2023

## Citation

> AI Analytics. FDA recall Z-2319-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2319-2023. Source: US FDA. Licensed CC0.

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