American Contract Systems, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1700-2022)

Various neurology packs

Class II

Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSRLMNEINTC, 2105181, 870211, 63990989 2) LSRSWRSPNC, 2105251, 861211, 63990357 3) LSRLMNEUROG, 2106161, 845211, 44139500 4) LSRSMHNEURE, 2108101, 793211, 44139500 5) LSRNEURCRANIH, 2108171, 776211, 64123199 6) LSRLMNEUROG, 2110011, 730211, 64316283 7) UINR44M, 2104162, 896211, 64033036 8) TNNE17Y, 2109081, 750211, 64224067 9) SLCR80E, 2104262, 884211, 63986071-006 10) GISP04A, 2104293, 881211, 63985242-006 11) FHNE25Y, 2107083, 811211, 64110740-006 12) BHLA24L, 2108253, 763211, 64205048-006 13) CBAC47F, 2109092, 749211, 64209378-006 14) SLCN72B, 2109161, 741211, 64208359-006 15) BHCR54D, 2104132, 901211, 64072795-006 16) BHCR54D, 2104132, 901211, 64072796-006 17) BHCR54D, 2104132, 901211, 64072273-006 18) BHLM30D, 2105111, 874211, 64062457-006 19) BHCR54D, 2105252, 861211, 64063353-006 20) BHLM30D, 2107091, 819211, 64088774-006 21) BHLM30D, 2107091, 819211, 64088775-006 22) BHLM30D, 2107091, 819211, 64088776-006 23) BHCR54D, 2107161, 810211, 64088824-006 24) BHCR54D, 2107161, 810211, 64088823-006 25) BHLM30D, 2108202, 770211, 64001247-006 26) BHLM30D, 2108202, 770211, 64001248-006 27) BHLM30D, 2108202, 770211, 64001249-006 28) BHLM30D, 2108202, 770211, 64001250-006 29) BHCR54D, 2109022, 757211, 63998620-006 30) BHCR54D, 2109022, 757211, 63998619-006 31) BHCR54D, 2109022, 757211, 63998618-006 32) UMNA22B, 2109292, 728211, 64310294-006 33) DVSP33E, 2104302, 884211, 64064626-006 34) MCSP61F, 2107021, 819211, 64128815-006 35) SJSC27F, 2107091, 813211, 44173743-005 36) SANE32G, 2108091, 784211, 44170921-005 37) MCSP61F, 2108091, 785211, 64138850-006

Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX

Voluntary: Firm initiated