# FDA recall Z-2312-2023

> **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. ABLATION PACK, Model Number: DYNJ40629B;       b. AV FISTULA PACK, Model Number: DYNJ81410B;     c. BARIATRIC KIT, Model Number: DYNJ901145G;       d. BARIATRIC LAPAROSCOPY R-Y PACK, Model Number: DYNJC9299M, DYNJC9299O;       e. BARIATRIC PACK, Model Number: DYNJ24459P;       f. CENTRAL CATHETER INSERTION PK, Model Number: DYNJ36242;       g. CYSTO PACK, Model Number: DYNJ60667C, DYNJ60667D, DYNJ60667F, DYNJ83942;       h. DBD-FETOSCOPIC, Model Number: DYNJ905761A;       i. DBD-FREE FLAP NO DRAPE PACK NTX, Model Number: DYNJ68447B;       j. DBD-HILLCREST PCNL PACK, Model Number: DYNJ69204A;       k. DIEP, Model Number: DYNJ901296B;       l. DIEP FLAP, Model Number: DYNJ66867A;       m. DONOR FREE FLAP PACK-LF, Model Number: DYNJ0426069N;       n. ECMO PACK, Model Number: DYNJ82517;       o. ENDOLUMINAL ACCESSORY PACK, Model Number: DYNJ44210B;       p. ENDOVASCULAR, Mode

## 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-2312-2023
- **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-2312-2023

## Citation

> AI Analytics. FDA recall Z-2312-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2312-2023. Source: US FDA. Licensed CC0.

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