# FDA recall Z-2320-2023

> **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. DR. ROSEN VEIN PACK, Model Number: DYNJ67517;     b. DR. VANBOSSE LOWER EXT PACK, Model Number: DYNJ51416B;   c. DRAINAGE TRAY, Model Number: DYNJ42913, DYNJ42913A;     d. ECMO PACK, Model Number: DYNJ61243;     e. EGG RETRIEVAL PACK, Model Number: DYNJ66291, DYNJ66291A;     f. EH TAVR PACK, Model Number: DYNJ57449A;     g. ELVS PACK-LF, Model Number: DYNJ26940G;     h. ENDO AAA HYBRID CHRG, Model Number: DYNJ60126;     i. ENDOVASCULAR OR PACK, Model Number: DYNJ54265;     j. ENDOVASCULAR PACK, Model Number: DYNJ59085;   k. ENDOVASCULAR PACK-LF, Model Number: DYNJ42831D;   l. ENDOVENOUS ABLATION PACK, Model Number: DYNJ53435C;   m. ENDOVENOUS BASIC PACK, Model Number: DYNJ48456B;   n. ENDOVENOUS CORE PACK, Model Number: DYNJ59168;   o. ENDOVENOUS PACK, Model Number: DYNJ58228;   p. ENS BIOPSIE THYROIDE-HEJ-LF, Model Number: DYNJ62443;   q. EP LAB, Model Number: DYNJ59392C; 

## 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-2320-2023
- **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-2320-2023

## Citation

> AI Analytics. FDA recall Z-2320-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2320-2023. Source: US FDA. Licensed CC0.

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