FDA Device recall Z-1691-2022

Various Pacemaker Packs, Cardio Thoracic Packs

FDA Device
Class II
ongoing
Published 2022-09-14

On 2022-09-14 the FDA classified a Class II recall of Various Pacemaker Packs, Cardio Thoracic Packs by American Contract Systems, citing product was exposed to multiple sterilization cycles without validation for multiple exposures.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1691-2022
Classification	Class II
Status	ongoing
Initiated	2022-06-16
Published	2022-09-14
Last updated	2026-09-13 11:56 UTC
Company	American Contract Systems
Distribution	AZ, FL, IA, IL, MA, MN, MO, NE, OH, PA, RI, SD, TX

Product

Various Pacemaker Packs, Cardio Thoracic Packs

Reason

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

Identifiers

code_info	Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSREPCUSTOML, 2106181, 835211, 44251067 2) LSRCVBASI… 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 2

code_info

Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSREPCUSTOML, 2106181, 835211, 44251067 2) LSRCVBASI…

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 2

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1691-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.