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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. CHN
Recalled August 9, 2023 · FDA recall Z-2333-2023 · MEDLINE INDUSTRIES, LP - Northfield
Hazard
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. · FDA Class II
Units
7,462 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. CHN OR DAVINCI PROSTATE, Model Number: DYNJ902540N; b. CUSTOM GYN, Model Number: DYNJ63257B; c. DBD-AMNIOCENTESIS PACK-LF, Model Number: DYNJ0771979C; d. DBD-GYN EXP LAPAROTOMY, Model Number: DYNJ906578F; e. DBD-GYN LITHOTOMY, Model Number: DYNJ906579F; f. DBD-GYN LS, Model Number: DYNJ906616G; g. DBD-ROBOTICS GYN, Model Number: DYNJ905824I; h. GYN EXP LAPAROTOMY, Model Number: DYNJ906578D; i. GYN LITHOTOMY, Model Number: DYNJ906579A, DYNJ906579B, DYNJ906579D, DYNJ906579F; j. GYN LS, Model Number: DYNJ906616A, DYNJ906616B, DYNJ906616C, DYNJ906616D, DYNJ906616F; k. GYN ROBOTIC CUSTOM PACK-LF, Model Number: DYNJ0752001K; l. ROBOTIC, Model Number: DYNJ904343D, DYNJ904343F; m. ROBOTIC GYN SSC, Model Number: DYNJ60009B, DYNJ60009C; n. ROBOTIC PACK-LF, Model Number: DYNJ904250G; o. ROBOTIC PROSTATECTOMY, Model Number: DYNJ905826G; p. ROBOTIC-LF, Model Number: DYNJ904254G, DYNJ904254I; q. ROBOTICS GYN, Model Number: DYNJ905824F, DYNJ905824G, DYNJ905824I; r. SSC GU ROBOTIC PACK, Model Number: DYNJ64027A, DYNJ64027B;
Manufacturer(s)
MEDLINE INDUSTRIES, LP - Northfield
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →