Z-2324-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 9, 2023
- Initiation Date
- May 15, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19,907 kits
Product Description
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 for Recall
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.
Code Information
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 Number: 019348946253. o. Model Number: DYNDV2385, UPC Number: 019348947559.