Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter — Class II medical device recall Z-2113-2020
Terminated recall by Stryker Sustainability Solutions, reported 2021-02-03, distributed in AZ, CA, FL, GA, ID, IL, IN, KS…. A subset of temporary intracardiac ultrasound catheters are labeled with the incorrect expiration date. They a
| Recall number | Z-2113-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Sustainability Solutions, Tempe, AZ, United States |
| Recall initiated | 2020-03-27 |
| Classified | 2020-05-22 |
| Reported by FDA | 2021-02-03 |
| Terminated | 2022-10-14 |
| Distributed | AZ, CA, FL, GA, ID, IL, IN, KS, MA, MO, PA, TN, TX, VA, WA, WV |
| Quantity | 101 units |
| Reason classes | labeling, sterility |
| UPC / GTIN / UDI-DI | 07613327376067 |
| Model numbers | D087031 |
Product
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
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2113-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.