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MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGI
Recalled August 9, 2023 · FDA recall Z-2295-2023 · MEDLINE INDUSTRIES, LP - Northfield
Hazard
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. · FDA Class II
Units
29,126 kits
Sold at
Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.
Description
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAM TRAY, Model Number: DYNJ33638J; b. BLOCK TRAY, Model Number: DYNJRA1543; c. BMT- NERVE PERIPH PK, Model Number: DYNJRA1247; d. CVOR ANGIOGRAPHY PACK-LF, Model Number: DYNJ42367B; e. FEMORAL BLOCK TRAY, Model Number: DYNJRA1739; f. NERVE BLOCK ACCESSORY PACK, Model Number: DYNJ0134147D; g. NERVE BLOCK PREP TRAY, Model Numbers: DYNJRA1220, DYNJRA1571; h. NERVE BLOCK SUPPORT TRAY, Model Number: DYNJRA1109A; i. NERVE BLOCK TRAY, Model Numbers: DYNJRA0656A, DYNJRA1287A, DYNJRA1604; j. NERVE BLOCK TRAY/PREFERRED, Model Number: DYNJRA0725; k. PK, RADIOLOGY-NEURO-IR, Model Number: DYNJ51107B; l. SINGLE SHOT NERVE BLOCK TRAY, Model Number: DYNJRA1773; m. ULTRASOUND BLOCK PREP TRAY, Model Number: PAIN1622A; n. UNIVERSAL BLOCK TRAY/2, Model Number: DYNJRA1635A;
Manufacturer(s)
MEDLINE INDUSTRIES, LP - Northfield
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →