Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
Recall
- Recall Number
- Z-2689-2024
- Event Number
- 95038
- Firm
- Stryker Sustainability Solutions
- FEI Number
- 3009350690
- Product Code
- IKD
- Status
- Open, Classified
- Root Cause
- Labeling mix-ups
- Initiated
- July 2, 2024
- Posted
- August 20, 2024
- Address
- 1810 W Drake Dr, Tempe, AZ, 85283-4327
Description
Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
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.
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 [email protected] Quality problems should be reported to the firm via phone +1-888-763-8803 or email http://www.stryker.com/productexperience
US Nationwide distribution in the states of FL, WY, AZ, CA, LA, TX, MI, OR, CO, MS, TN, WI.
38,850