# FDA recall Z-2309-2023

> **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. CAROTID, Model Number: DYNJ54287A;       b. CAROTID PACK, Model Number: DYNJ66190;     c. CAROTID SUPPLY, Model Number: DYNJ905622C;       d. CAROTID-LF, Model Number: DYNJ901745J;       e. CENTRAL LINE INSERTION, Model Number: DYNJ63347A;       f. CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G;       g. DBD-CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I;       h. DBD-IR THYROID PACK THLUF642-LF, Model Number: DYNJ47716B;       i. ENT FREE FLAP, Model Number: SYNJ910018A;       j. ENT FREE FLAP PACK, Model Number: DYNJ67954A;       k. FEM CAROTID PACK, Model Number: DYNJ65706;       l. FLAP ENT FREE, Model Number: DYNJ905340A;       m. FREE FLAP PACK-LF, Model Number: DYNJ20495J;       n. PACK HEAD   NECK, Model Number: DYNJ30245;       o. SVMMC CAROTID PACK, Model Number: DYNJ43861D;       p. TAVR FAIRFAX, Model Number: DYNJ63634A;       q. VNUS TRAY, Model

## 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-2309-2023
- **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-2309-2023

## Citation

> AI Analytics. FDA recall Z-2309-2023. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-2309-2023. Source: US FDA. Licensed CC0.

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