Z-1803-2018 Class II Terminated
FDA device recall Z-1803-2018 was initiated by Bard Peripheral Vascular Inc on Apr 16, 2018 and is designated Class II. 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… The recall status is terminated (terminated Mar 2, 2021). Affected quantity: 130 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 23, 2018
- Initiation Date
- Apr 16, 2018
- Termination Date
- Mar 2, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 130 units
Product Description
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.
Distribution Pattern
Nationwide Distribution
Code Information
UDI: (01)00801741067907(17)191207(10)VTBZ0193, Lot Number: VTBZ0193
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1803-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026