# FDA recall Z-2331-2023

> **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. ANGIO, Model Number: DYNJ905151A;       b. ANGIO/VENO PACK, Model Number: DYNJ58346A;     c. ANGIOGRAPHIC PACK, Model Number: DYNJ57442C, DYNJ64081A;    d. ANGIOGRAPHY PACK, Model Number: DYNJ65963;       e. ANGIOPLASTY PACK-LF, Model Number: DYNJ64655;       f. ARTHROGRAM TRAY, Model Number: SPEC0232;       g. BASIC CATH/ANGIO, Model Number: DYNJ62591A;       h. BASIC PACK, Model Number: DYNJ39752A;       i. C.I.C.N. ANGIO PACK, Model Number: DYNJ53064B;       j. CATH ANGIO PACK, Model Number: DYNJ64050;       k. DBD-KIT NEURO CAROTID SETUP, Model Number: DYKMBNDL148;       l. DBS PACK-LF, Model Number: DYNJ0878178I;       m. GENERAL ANGIO PACK, Model Number: DYNJ57760A;       n. GHIASSI NEURO ANGIO PACK-LF, Model Number: DYNJ57032C;       o. IR NEURO PACK, Model Number: DYNJ39198L, DYNJ39198N;       p. KIT OR AORTOGRM ANGIOPLAST PHT, Model Number: DYNJ906086A;       q. 

## 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-2331-2023
- **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-2331-2023

## Citation

> AI Analytics. FDA recall Z-2331-2023. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-2331-2023. Source: US FDA. Licensed CC0.

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