Recall Z-2113-2020 ยท OWQ Reprocessed Intravascular Ultrasound Catheter
Stryker Sustainability Solutions
Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical, Size 9F (3.2mm), Length 90 cm, Sterile EO, Rx Only, Quantity 1, UDI: 07613327376067
| Date | Jun 1, 2020 (initiated Mar 27, 2020) |
| Status | Terminated |
| Reason | A subset of temporary intracardiac ultrasound catheters are labeled with the incorrect expiration date. They are mislabeled as having a shelf life of two years, while the actual shelf life is one year. The earliest affected product will expire in May 2020. Use of mislabeled devices may lead to hazards sterility breach, component breakdown or delay in treatment. |
| Root cause | Labeling False and Misleading |
| Action | The firm will execute the recall in four phases: 1) Provide the Urgent Medical Device Recall Customer Notification Letter and Recall Business Reply Form to sales representatives via UPS on 3/27/2020 to notify affected customers; 2) Send the Urgent Medical Device Recall Customer Notification Letter and Recall Business Reply Form directly to affected customers; 3) Follow up phone calls and/or emails to nonrespondent customers as needed; 4) Additional follow up attempts to non-respondent customers as needed. The Urgent Medical Device Recall Customer Notification Letter and Recall Business R |
| Quantity | 101 units |
| Distribution | US: AZ, CA, FL, GA, ID, IL, IN, KS, MA, MO, PA, TN, TX, VA, WA, WV OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182238 | Reprocessed ViewFlex Xtra ICE Catheter Stryker Sustainability Solutions, May 8, 2019 |