FDA Device recall Z-1689-2022

Various Angiography packs/trays

FDA Device
Class II
ongoing
Published 2022-09-14

On 2022-09-14 the FDA classified a Class II recall of Various Angiography packs/trays 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-1689-2022
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 Angiography packs/trays

Reason

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

Identifiers

code_info	Tray Number, Sterilization Lot, Lot Number, and Bag Serial Number: 1) LSRARTDATANGA,2105051, 884211, 44136929 2) LSRAN… Tray Number, Sterilization Lot, Lot Number, and Bag Serial Number: 1) LSRARTDATANGA,2105051, 884211, 44136929 2) LSRANGIRM21G,2105111, 874211, 63991913 3) LSRCFHANGD,2106031, 854211, 14887381 4) LSRARTDATANGA,2107102, 821211, 44256256 5) LSRARTDATANGA,2107102, 821211, 44256255 6) LSRARTDATANGA,2110011, 742211, 44373255 7) LSRARTDATANGA,2110011, 742211, 44373260 8) LMAN19U,2106292, 824211, 64169682 9) IHAN02S,2108111, 782211, 64190032 10) ANCA80AG,2109161, 743211, 64222813 11) SLPC34,2104022, 908211, 44127417-005 12) MHHY51F,2104151, 895211, 63978560-006 13) CXAN39N,2105072, 873211, 14875221-004 14) FHAG11X,2105072, 873211, 44111418-005 15) MHIR99AF,2105132, 868211, 63958625-006 16) BHAN91L,2105211, 860211, 44107976-005 17) ANCA80AG,2105212, 860211, 63956879-006 18) UDIN23AB,2105253, 855211, 63955146-006 19) SLPC34H,2106011, 853211, 44130251-005 20) SLPC34H,2106232, 827211, 43995487-005 21) SLPC34H,2106232, 827211, 43995488-005 22) FHAG11X,2106252, 825211, 43993760-005 23) FHAG11X,2106

code_info

Tray Number, Sterilization Lot, Lot Number, and Bag Serial Number: 1) LSRARTDATANGA,2105051, 884211, 44136929 2) LSRAN…

Tray Number, Sterilization Lot, Lot Number, and Bag Serial Number: 1) LSRARTDATANGA,2105051, 884211, 44136929 2) LSRANGIRM21G,2105111, 874211, 63991913 3) LSRCFHANGD,2106031, 854211, 14887381 4) LSRARTDATANGA,2107102, 821211, 44256256 5) LSRARTDATANGA,2107102, 821211, 44256255 6) LSRARTDATANGA,2110011, 742211, 44373255 7) LSRARTDATANGA,2110011, 742211, 44373260 8) LMAN19U,2106292, 824211, 64169682 9) IHAN02S,2108111, 782211, 64190032 10) ANCA80AG,2109161, 743211, 64222813 11) SLPC34,2104022, 908211, 44127417-005 12) MHHY51F,2104151, 895211, 63978560-006 13) CXAN39N,2105072, 873211, 14875221-004 14) FHAG11X,2105072, 873211, 44111418-005 15) MHIR99AF,2105132, 868211, 63958625-006 16) BHAN91L,2105211, 860211, 44107976-005 17) ANCA80AG,2105212, 860211, 63956879-006 18) UDIN23AB,2105253, 855211, 63955146-006 19) SLPC34H,2106011, 853211, 44130251-005 20) SLPC34H,2106232, 827211, 43995487-005 21) SLPC34H,2106232, 827211, 43995488-005 22) FHAG11X,2106252, 825211, 43993760-005 23) FHAG11X,2106

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-1689-2022%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.