Recall Z-2689-2024 ยท IKD Cable, Electrode
Stryker Sustainability Solutions
Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
| Date | Aug 20, 2024 (initiated Jul 2, 2024) |
| Status | Open, Classified |
| 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 |
| Quantity | 38,850 |
| Distribution | US Nationwide distribution in the states of FL, WY, AZ, CA, LA, TX, MI, OR, CO, MS, TN, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.