# FDA recall Z-2305-2023

> **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. A V FISTULA, Model Number: DYNJ65711;     b. ACCESS CATHETER, Model Number: DYNJ64141A;   c. ACCESS PICC PACK, Model Number: DYNJ40682B;     d. ADULT EPIV INSERTION TRAY, Model Number: DYNDA2482;     e. AFCH CVC INSERTION, Model Number: DYNJ67534;     f. ANGIOGRAM-DECH-LF, Model Number: DYNJ81725;     g. ART LINE KIT ICH OR, Model Number: ART900;     h. ARTERIAL LINE PACK, Model Number: DYNJ49235D;     i. ARTERIOGRAM PACK, Model Number: DYNJ53095A, DYNJ55169G;     j. AV FISTULA, Model Number: DYNJ64143A, DYNJ905219A, DYNJ906341C, DYNJ906945;     k. AV FISTULA PACK, Model Number: DYNJ52093I, DYNJ62733, DYNJ66916, DYNJ67178;     l. AV FISTULA PACK-LF, Model Number: DYNJ48428C, DYNJ64499A, DYNJ69167;     m. AV SHUNT PACK-LF, Model Number: DYNJ0781844W;     n. BARIATRIC KIT, Model Number: DYNJ901145F;     o. BASIC VEIN PACK, Model Number: DYNJ69426;     p. BCH VEIN ABLATION, Mo

## 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-2305-2023
- **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-2305-2023

## Citation

> AI Analytics. FDA recall Z-2305-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2305-2023. Source: US FDA. Licensed CC0.

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