5 Lead Cable System (Stryker) – Packaging Mixup (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
Brand
Stryker Sustainability Solutions
Lot Codes / Batch Numbers
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
Products Sold
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
Stryker Sustainability Solutions is recalling Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A due to 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 co. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 7/2/24, recall notices were sent to customers informing them of the following: 1) Inspect affected devices for "TruLink" branding and if found, remove them from their point of use. 2) If any of the affected products have been forwarded to additional facilities (including but not limited to distribution warehouses), please contact these facilities and communicate this recall to them. Please instruct these facilities to complete the Business Reply Form. 3) Complete and return the business reply form via email to SSSPFA@stryker.com Quality problems should be reported to the firm via phone +1-888-763-8803 or email http://www.stryker.com/productexperience
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026