FDA Device recall Z-2325-2023
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel
- FDA Device
- Class II
- ongoing
- Published 2023-08-09
On 2023-08-09 the FDA classified a Class II recall of Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel by Medline Industries Northfield, citing potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2325-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-15 |
| Published | 2023-08-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC INFANT INSERTION PACK, Model Number: CVI4770A; b. INSERTION BUNDLE, Model Number: DT21275; c. MIDLINE DRESSING CHANGE KIT, Model Number: EBSI1464; d. MIDLINE INSERTION KIT, Model Number: DT20155; e. PICC LINE DRESSING TRAY, Model Number: DT22045; f. UNIVERSAL DRESSING PPE KIT, Model Number: DT22065; g. UNIVERSAL DRESSING & PPE KIT, Model Number: DT22065; h. VA MAINTENANCE PACK, Model Number: EBSI1382;
Reason
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Identifiers
| upc | 10653160350828 |
|---|---|
| upc | 10653160318934 |
| upc | 10193489198959 |
| upc | 10653160290070 |
| upc | 10653160325659 |
| upc | 065316032660 |
| upc | 10653160326601 |
| upc | 10193489196269 |
| code_info | All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2…All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: CVI4770A, UPC Number: 10653160350828. b. Model Number: DT21275, UPC Number: 10653160318934. c. Model Number: EBSI1464, UPC Number: 10193489198959. d. Model Number: DT20155, UPC Number: 10653160290070. e. Model Number: DT22045, UPC Number: 10653160325659. f. Model Number: DT22065, UPC Number: 065316032660. g. Model Number: DT22065, UPC Number: 10653160326601. h. Model Number: EBSI1382, UPC Number: 10193489196269. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2325-2023%22
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