Medline Industries, LP recalls Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, M

Hazard / Issue

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: 1) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525030011; 2) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525050004; 3) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525100025; 4) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525100068; 5) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525020012; 6) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525040038; 7) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525060015; 8) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525060041; 9) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525080004; 10) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525080039; 11) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72519120082; 12) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72519120084; 13) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72519120097; 14) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520020055; 15) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520030039; 16) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520030064; 17) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520030074; 18) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520050047; 19) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520060018; 20) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520060019; 21) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520070016; 22) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520080003; 23) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520080004; 24) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520080059; 25) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520100068; 26) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520120003; 27) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520120004; 28) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521040001; 29) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521050060; 30) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521050064; 31) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521050167; 32) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521060070; 33) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521070019; 34) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521070099; 35) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521080017; 36) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521090001; 37) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521090015; 38) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521100005; 39) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521100033; 40) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521110009; 41) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521110016; 42) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521120009; 43) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521120031; 44) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522010013; 45) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522020010; 46) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522030020; 47) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522040019; 48) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522050012; 49) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522050015; 50) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522060019; 51) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522060052; 52) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522070003; 53) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522080008; 54) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522110004; 55) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522110040; 56) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522120006; 57) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72523100020; 58) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72523100063; 59) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72523110004; 60) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72523120076; 61) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524010036; 62) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524010087; 63) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524030056; 64) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524040002; 65) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524050034; 66) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524060001; 67) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524060034; 68) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524060098; 69) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524070001; 70) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524080004; 71) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524090003; 72) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524090078; 73) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524100004; 74) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524100099; 75) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524110013; 76) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524120003; 77) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525010001; 78) DYNJP8401, UDI-DI: 10080196740710(each), 40080196740711(case), Lot Number: 72521080034