Disposable 5 Lead Cable and Lead Wire System recall
Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
Why was Disposable 5 Lead Cable and Lead Wire System recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
- Recalling firm
- Stryker Sustainability Solutions
- Quantity
- 38,850
- Distribution
- US Nationwide distribution in the states of FL, WY, AZ, CA, LA, TX, MI, OR, CO, MS, TN, WI.
- Recall date
- August 28, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)