Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz… — Class II medical device recall Z-2325-2023
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2023-08-09, distributed nationwide. Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
| Recall number | Z-2325-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2023-05-15 |
| Classified | 2023-08-03 |
| Reported by FDA | 2023-08-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, CN, CR, IN, LB, PA, QA, SA, SG |
| Quantity | 13,881 kits |
| Reason classes | labeling, sterility |
| UPC / GTIN / UDI-DI | 10193489196269, 10193489198959, 10653160290070, 10653160318934, 10653160325659, 10653160326601, 10653160350828 |
| Model numbers | CVI4770A, DT20155, DT21275, DT22045, DT22065, EBSI1382, EBSI1464 |
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 for recall
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2325-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.