# FDA recall Z-2302-2023

> **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. OPEN HEART CDS-LF, Model Number: CDS840451L;     b. OPEN HEART LINE SET UP, Model Number: DYNJ908179, DYNJ908179A;   c. OPEN HEART PACK, Model Number: DYNJ43741B, DYNJ66216, DYNJ66216A, DYNJ66216B, DYNJ66216C;     d. OPEN HEART PACK A B, Model Number: DYNJ53984G;     e. OPEN HEART PACK A & B, Model Number: DYNJ0283397T, DYNJ0283397U, DYNJ53984F, DYNJ53984G;     f. OPEN HEART PACK-LF, Model Number: DYNJ0371669N;     g. OPEN HEART PACK-RF-LF, Model Number: DYNJ22232W;     h. OPEN HEART PART 2, Model Number: DYNJ901075O, DYNJ901075P;     i. OPEN HEART PROCEDURE, Model Number: DYNJ901821A;     j. OPEN HEART TAVR CONVERSION PK, Model Number: DYNJ63153B;     k. OPEN HEART TAVR PACK, Model Number: DYNJ63099F;     l. OPEN VASCULAR UE, Model Number: DYNJ907858A;     m. OPEN VASCULAR UE PACK, Model Number: DYNJ62451;     n. OR ENDOVASCULAR, Model Number: DYNJ906019B, DYNJ906019C;    

## 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-2302-2023
- **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-2302-2023

## Citation

> AI Analytics. FDA recall Z-2302-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2302-2023. Source: US FDA. Licensed CC0.

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