# FDA recall Z-2321-2023

> **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. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755B;     b. PEDIATRIC MAX BARRIER KIT-LF, Model Number: DYNJ40306A;   c. PERC PACK-LF, Model Number: DYNJ0774759P;  d. PERCUTANEOUS VASCULAR CDS, Model Number: DYNJ902261D;     e. PERIPHERAL NERVE BLOCK KIT/P, Model Number: DYNJRA1747;     f. PERIPHERAL PACK, Model Number: DYNJ44960D;     g. PERIPHERAL ULTRASOUND CATHETER, Model Number: DYNDV2285, MNS9865;     h. PERIPHERAL VASCULAR GRAFT PACK, Model Number: DYNJ904401B;     i. PERMACATH-LF, Model Number: DYNJ42262D;     j. PHLEBECTOMY PACK, Model Number: DYNJ47502B;     k. PHYSIATRY PACK, Model Number: DYNJ67414;     l. PICC INSERT KIT-LESS THAN 3 FR, Model Number: PHS41739A;     m. PICC INSERTION PACK, Model Number: DYNJ60038;     n. PICC LINE DOUBLE LUMEN CDS, Model Number: CDS982858F;     o. PICC LINE INSERTION, Model Number: DYNJ39885A;     p. PICC LINE INSERTION WRO-LF, 

## 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-2321-2023
- **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-2321-2023

## Citation

> AI Analytics. FDA recall Z-2321-2023. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-2321-2023. Source: US FDA. Licensed CC0.

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