FDA recall Z-2298-2023

Product

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CRMC MINOR IR PROCEDURE PK-LF, Model Numbers: DYNJ61099B, DYNJ61099C; b. CRMC TUNNEL CATH TRAY-LF, Model Numbers: DYNJ61118C, DYNJ61118F; c. CUSTOM ANGIO TRAY, Model Number: DYNJ41649G; d. CUSTOM DUAL LUMEN 8.5 FRENCH CVC KIT, Model Number: ECVC2595; e. CV MINOR CDS, Model Numbers: CDS984100U, CDS984100V; f. CVC 16CM BUNDLE, Model Number: ECVC2225; g. CVC 3L 7F 20CM VANTEX, Model Number: ECVC7265A; h. CVC BUNDLE, Model Number: ECVC3235; i. CVC BUNDLE 16CM, Model Number: ECVC2335; j. CVC BUNDLE 20CM 3L, Model Number: ECVC5120B; k. CVC BUNDLE 4L 20CM, Model Number: ECVC5095B; l. CVC BUNDLE 7FR, 3L, 20CM, Model Numbers: ECVC6075, ECVC6460; m. CVC BUNDLE KIT 16CM, Model Number: ECVC2240A; n. CVC BUNDLE KIT 20CM, Model Number: ECVC2001; o. CVC BUNDLE KIT 7F 3L 16CM, Model Number: ECVC7205A; p. CVC BUNDLE KIT 7F 3L 20CM MULTIMED PI, Model Number: E

Reason for recall

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

Key facts

Status

Ongoing

Initiation date

2023-05-15

Report date

2023-08-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2298-2023