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

FDA device recall Z-2689-2024 · posted 2024-08-20 · Open, Classified

Recall details

Recalling firm

Stryker Sustainability Solutions

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.

Action taken

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

Root cause

Labeling mix-ups

Status

Open, Classified

Product code

IKD

Quantity affected

38,850

Distribution

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

Date initiated

2024-07-02

Date posted

2024-08-20

Location

Tempe, AZ