# FDA recall Z-2296-2023

> **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: DYNJ902507B;      b. ANGIO BASIN SET, Model Numbers: DYNJ46043D, DYNJ46043F;     c. ANGIO CATH COMBINED PACK, Model Numbers: DYNJ43609K, DYNJ43609L, DYNJ43609M, DYNJ43609N;      d. ANGIO DRAPE PACK, Model Number: DYNJ17624B, DYNJ44320F;      e. ANGIO DRAPE SPEC PROC PACK, Model Number: DYNJ47951A;      f. ANGIO LEFT HEART PACK, Model Number: DYNJ40632C;      g. ANGIO PACK, Model Numbers: DYNJ30141, DYNJ34361, DYNJ42903B, DYNJ43661B, DYNJ47226A, DYNJ50624A, DYNJ51239A, DYNJ58111C, DYNJ58126A, DYNJ62299, DYNJ62544, DYNJ65043A, DYNJ66398A, DYNJ66398B;      h. ANGIO PACK 2-A, Model Number: DYNJ60507A;      i. ANGIO PACK-LF, Model Numbers: DYNJ0373279L, DYNJ0373279M;     j. ANGIO TRAY, Model Numbers: DYNJ46153A, DYNJ46153B, DYNJ52121;      k. ANGIO TRAY W/CHLORAPREP, Model Number: DYNJ62742;      l. ANGIO/PICC PACK, Model Number: DYNJ36049;      m. ANGIOGR

## 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-2296-2023
- **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-2296-2023

## Citation

> AI Analytics. FDA recall Z-2296-2023. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-2296-2023. Source: US FDA. Licensed CC0.

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