Z-2689-2024 Class II Ongoing

Recalled by Stryker Sustainability Solutions — Tempe, AZ

Recall Details

Product Type
Devices
Report Date
August 28, 2024
Initiation Date
July 2, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
38,850

Product Description

Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A

Reason for Recall

Disposable 5 lead cable and lead wire system package that should contain lead systems, lead telemetry systems and a dual connect cable, may in fact contain, different ECG Leads, which are not approved for reprocessing, but that may have been reprocessed, which may lead to devices not performing as intended.

Distribution Pattern

US Nationwide distribution in the states of FL, WY, AZ, CA, LA, TX, MI, OR, CO, MS, TN, WI.

Code Information

UDI-DI: 07613327483918, Lots: 0000111423, 0000115940, 0000117907, 0000124226, 0000129992, 0000169328, 0000176893, 0000178122, 0000181676, 0000206244, 0000210519, 0000211431, 0000213251, 0000217965, 0000219223, 0000221089, 0000228136, 0000231266, 0000236744, 0000238102, 0000240411, 0000240412, 0000250305, 0000291346, 0000356647, 0000372559, 0000445734, 0000474297, 0000541414, 0000549776, 11875844, 11893791, 11899068, 11902434, HY91020484, 11915419, 11925385, 11928534, 11931083, 11939652, 11947005, 11954851, 11963779, 11970640, 11977657, 11980331, 11984244, 11987875, 11991652, 11995462, 11995692, 12002389, 12010328, 12023953, 12026719, 12030554, 12039815, 12053079, 12056896, 12063693, 12080618, 12088836, 12093498, 12098299, 12102817, 12112224, 12148349, 12160590, 12170555, 12179425, 12185364, 12202282, 12204592, 12226747, 12238271, 12251638, 12253223, 12256926, 12260046, 12260098, 12271761, 12275519, 12277794, 12296434, 12327605, 12330999, 12351043, 12354510, 12355927, 12361109, 12363874, 12385821, 12386574, 12393911, 12401022, 12401392, 12409053, 12425416, 12431954, 12461855, 12469153, 12487497, 12490745, 12867127, 12879311, 12880822, 12892753, 12909629, 12939581, 12941498, 12959145, 12961324, 12963724, 12974181, 12998830, 13000131, 13006321, 13033322, 13051563, 13060599, 13067891, 13076246, 13092763, 13116447, 13121654, 13134031, 13146568, 13152147, 13158318, 13166734, 13203951, 13227500, 13242807, 13254161, 13280000, 13305113, 13325718, 12519983, 12532241, 12536829, 12541571, 12563008, 12564143, 12570286, 12581262, 12602792, 12607307, 12610241, 12616233, 12617893, 12647916, 12673690, 12678802, 12687516, 12693216, 12698775, 12701121, 12708984, 12735304, 12776269, 12777021, 12792610, 12795271, 12807688, 12809489, 12814655, 12824606, 12830261, 12851958, 12853941, 12867127, 12879311, 12880822, 12892753, 12909629, 12939581, 12941498, 12959145, 12961324, 12963724, 12974181, 12998830, 13000131, 13006321, 13033322, 13051563, 13060599, 13067891, 13076246, 13092763, 13116447, 13121654, 13134031, 13146568, 13152147, 13158318, 13166734, 13203951, 13227500, 13242807, 13254161, 13280000, 13305113, 13325718