BARD PERIPHERAL VASCULAR SEEKER — Class II medical device recall Z-1803-2018
Terminated recall by Bard Peripheral Vascular Inc, reported 2018-05-23, distributed nationwide. Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the ca
| Recall number | Z-1803-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bard Peripheral Vascular Inc, Tempe, AZ, United States |
| Recall initiated | 2018-04-16 |
| Classified | 2018-05-11 |
| Reported by FDA | 2018-05-23 |
| Terminated | 2021-03-02 |
| Distributed | Nationwide (US) |
| Quantity | 130 units |
| Reason classes | microbial contamination, sterility |
| UPC / GTIN / UDI-DI | 00801741067907 |
| Lot numbers | VTBZ0193 |
| Model numbers | K15014 |
Product
BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.014", 150 cm, REF SK15014. Intended to support a guidewire during access into the vasculature.
Reason for recall
Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. The bacterial endotoxin levels for the catheters are within acceptable levels; however, if bacterial endotoxins are present on the packaging hoops it may have the potential for cross-contamination in a clinical setting.
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-1803-2018. 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.