# FDA recall Z-2300-2023

> **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. AAA PACK, Model Number: DYNJ44847I;    b. ABDOMINAL VASCULAR PACK, Model Number: DYNJ82578;   c. ABDOMINAL VASCULAR-LF, Model Numbers: DYNJ905291B, DYNJ905291C;   d. ABLATION PACK, Model Number: DYNJ61957A;   e. ACCESSORY OPEN HEART PACK, Model Number: DYNJ36600F;   f. ADULT CORONARY PACK, Model Numbers: DYNJV0275J, DYNJV0275K, DYNJV0275L, DYNJV0275M;   g. AFIB PACK, Model Number: DYNJ69682;   h. ALT MINOR VASCULAR CDS, Model Number: CDS840493F;   i. ANGIO-VASCULAR, Model Number: DYNJ24272C;   j. ARM VASCULAR-LF, Model Number: DYNJ905290D;   k. ARTERIAL/VENOUS ACCESS TRAY, Model Number: DYNDC3038;   l. ARTERIOGRAM PACK, Model Numbers: DYNJ81636, DYNJ81636A;   m. ARTERIOGRAM PACK 2, Model Number: DYNJ83051;   n. AUD MAJOR VASC PK-LF, Model Number: DYNJ40728D;   o. AUD MAJOR VASCULAR-LF, Model Number: DYNJ40728A, DYNJ40728B, DYNJ40728C;   p. AV FIST PACK, Model Number: DYNJ83

## 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-2300-2023
- **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-2300-2023

## Citation

> AI Analytics. FDA recall Z-2300-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2300-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*