Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
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. Quantity: 29,126 kits Lot/code info: All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ33638J, UPC Number: 019348956435. b. Model Number: DYNJRA1543, UPC Number: 019348921766. c. Model Number: DYNJRA1247, UPC Number: 019348950391. d. Model Number: DYNJ42367B, UPC Number: 019348921151. e. Model Number: DYNJRA1739, UPC Number: 019348926312. f. Model Number: DYNJ0134147D, UPC Number: 088994293734. g. Model Number: DYNJRA1220, UPC Number: 088827779503; Model Number: DYNJRA1571, UPC Number 019348926473. h. Model Number: DYNJRA1109A, UPC Number: 019348925132. i. Model Number: DYNJRA0656A, UPC Number: 088994222511; Model Number: DYNJRA1287A, UPC Number: 019348977309; Model Number: DYNJRA1604, UPC Number 019348929981. j. Model Number: DYNJRA0725, UPC Number: 019348926312. k. Model Number: DYNJ51107B, UPC Number: 019348981047. l. Model Number: DYNJRA1773, UPC Number: 019348986297. m. Model Number: PAIN1622A, UPC Number: 019348989169. n. Model Number: DYNJRA1635A, UPC Number: 019348936764.
019348956435, 019348921766, 019348950391, 019348921151, 019348926312, 088994293734, 088827779503, 019348926473, 019348925132, 088994222511, 019348977309, 019348929981, 019348981047, 019348986297, 019348989169, 019348936764
Official record: FDA (Device enforcement) ↗
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