FDA Device recall Z-2324-2023
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-2324-2023 |
| 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. CENTRAL LINE INSERT KIT W/O CA, Model Number: CVI3755; b. CENTRAL LINE KIT, Model Number: DYNDC2582, DYNDC2582A; c. CENTRAL LINE PACK-COMPANION, Model Number: DYNJ47215D; d. CENTRAL LINE TRAY, Model Number: DYNJ42902B; e. CENTRAL LINE UNIVERSAL INSERTION, Model Number: CVI3780; f. CLOSURE PACK, Model Number: DYNJ83054A; g. DBD-PICC LINEPACK PCLUI642-LF, Model Number: DYNJ47717A; h. ER CENTRAL LINE KIT, Model Number: P155508B, P155508C; i. HEMODIALYSIS CENTRAL LINE, Model Number: DYNJ63347; j. LINE KIT, Model Number: DYNJ47987A; k. PEDIATRIC CENTRAL LINE KIT, Model Number: DYNJ38885B; l. PK CUST CENTRAL LINE PACK, Model Number: DYNJ60586; m. TRAY LACERATION, Model Number: DYNDL1134A; n. TUNNEL LINE PACK, Model Number: DYNJ67990; o. ULTRASOUND GUIDED IV/MIDLINE K, Model Number: DYNDV2385;
Reason
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Identifiers
| upc | 019348981943 |
|---|---|
| upc | 10889942670444 |
| upc | 10193489198164 |
| upc | 088827774302 |
| upc | 088827779800 |
| upc | 019348943486 |
| upc | 019532731051 |
| upc | 019348945452 |
| upc | 019532709134 |
| upc | 019348981031 |
| upc | 088994268310 |
| upc | 019348946233 |
| upc | 019348952804 |
| upc | 008019699476 |
| upc | 019348946253 |
| upc | 019348947559 |
| 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: CVI3755, UPC Number: 019348981943. b. Model Number: DYNDC2582, UPC Number: 10889942670444; Model Number: DYNDC2582A, UPC Number: 10193489198164. c. Model Number: DYNJ47215D, UPC Number: 088827774302. d. Model Number: DYNJ42902B, UPC Number: 088827779800. e. Model Number: CVI3780, UPC Number: 019348943486. f. Model Number: DYNJ83054A, UPC Number: 019532731051. g. Model Number: DYNJ47717A, UPC Number: 019348945452. h. Model Number: P155508B, UPC Number: 019532709134; Model Number: P155508C, UPC Number: 019532709134. i. Model Number: DYNJ63347, UPC Number: 019348981031. j. Model Number: DYNJ47987A, UPC Number: 088994268310. k. Model Number: DYNJ38885B, UPC Number: 019348946233. l. Model Number: DYNJ60586, UPC Number: 019348952804. m. Model Number: DYNDL1134A, UPC Number: 008019699476. n. Model Number: DYNJ67990, UPC Numbe |
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-2324-2023%22
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