Various Pacemaker Packs, Cardio Thoracic Packs

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

Code information: Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSREPCUSTOML, 2106181, 835211, 44251067 2) LSRCVBASING, 2107102, 817211, 64116041 3) LSRSMVEINB, 2107221, 810211, 64119459 4) LSRCFHENDAE, 2107171, 807211, 64116602 5) UICT16E, 2108183, 771211, 15066268 6) BHOH94I, 2104141, 897211, 63987116-006 7) BHOH95, 2104301, 902211, 44123693-005 8) ANCV60AI, 2105201, 860211, 63956881-006 9) UDIP97AD, 2105201, 860211, 14858003-004 10) CEFS17I, 2105262, 855211, 44132805-005 11) FHPM10P, 2106092, 840211, 44129541-005 12) SLCV01E, 2107081, 812211, 64110741-006 13) SLEP03F, 2108271, 761211, 44314505-005 14) SLEP03F, 2108271, 761211, 44314504-005 15) CXCV91X, 2108311, 757211, 44315778-005 16) MECV98V, 2108312, 757211, 44313827-005 17) SAPA90X, 2108311, 758211, 64204754-006 18) SLCV01E, 2109161, 742211, 64208360-006 19) MEEP10F, 2109202, 740211, 64220361-006 20) UMOH42C, 2105072, 876211, 64061399-006 21) BHON40H, 2108122, 778211, 64095875-006 22) BHPM60F, 2108122, 779211, 44216056-005 23) BHCA27C, 2109072, 754211, 63997844-006 24) BHPM60F, 2109292, 728211, 44353475-005

Distribution pattern: 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