FDA recall Z-2299-2023

Product

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. MULTI-LUMEN CVC BUNDLE KIT, Model Number: ECVC475; b. MULTI-LUMEN CVC INSERTION BUNDLE, Model Number: ECVC3900; c. MULTIMED 16G 1L 20CM CVC STOCK+BUNDLE US, Model Number: STCVC20US; d. MULTIMED 7F 2L 16CM STOCK + BUNDLE US, Model Number: STCVC21US; e. MULTIMED 7F 3L 16CM CVC BUNDLE, Model Number: ECVC6585A; f. MULTIMED 7F 3L 20CM PI, Model Number: ECVC7235A; g. MULTIMED 7FR 16CM CVC STK + BUNDLE-US, Model Number: STCVC03US; h. MULTIMED 7FR 3L 16CM CVC BUNDLE, Model Number: ECVC6655A; i. MULTIMED 7FR 3L 20CM CVC BUNDLE-US, Model Number: ECVC7935; j. MULTIMED 7FR 3L 20CM CVC STK + BUNDLE-US, Model Number: STCVC04US; k. MULTIMED 7FR, 20CM, 3L CVC BUNDLE, Model Number: ECVC7670; l. MULTIMED 8.5F 20CM QUAD CVC BUNDLE, Model Number: ECVC7090; m. MULTIMED 8.5FR 16CM QUAD CVC BUNDLE, Model Number: ECVC6930; n. MULTIMED 8.5FR 2L 16CM CVC STK+BUNDLE-US,

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-2299-2023