FDA Medical Device Recalls (openFDA)
Stryker Sustainability Solutions: Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
- Recall number
- Z-2689-2024
- Recalling firm
- Stryker Sustainability Solutions
- Product
- Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
- Status
- Open, Classified
- Initiated
- 2024-07-02
- Posted
- 2024-08-20
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Labeling mix-ups
- Action
- 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
- Quantity
- 38,850
- Distribution
- US Nationwide distribution in the states of FL, WY, AZ, CA, LA, TX, MI, OR, CO, MS, TN, WI.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IKD
- Firm FEI
- 3009350690
- Firm city
- Tempe
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28