Device product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 16CM CENTRAL LINE BUNDLE, Model Number: STCVC2020; b. ARTERIAL LINE TRAY, Model Number: ART905; c. CATHETERLESS INSERTION KIT, Model Number: CVI4510; d. OR CATHETER INSERTION SETUP PACK, Model Number: ECVC7165A; e. VANTEX 7FR 3L 16CM CVC BUNDLE, Model Number: STCVC01145B; f. VANTEX TRIPLE LUMEN BUNDLE, Model Number: STCVC2000;
Z-2304-2023
Product summary
- Event
- Event 92399
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,218 kits
- Official record key
device-enforcement:Z-2304-2023
Official wording
Reason: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
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: STCVC2020, UPC Number: 10653160338765. b. Model Number: ART905, UPC Number: 10653160326557. c. Model Number: CVI4510, UPC Number: 10653160321194. d. Model Number: ECVC7165A, UPC Number: 10653160346760. e. Model Number: STCVC01145B, UPC Number: 10653160351924. f. Model Number: STCVC2000, UPC Number: 10653160336792.
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.
Derived failure modes
-
Unknown
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.