CLASS II Device recall · Reported 23 May 2018 · FDA Enforcement Report
Seeker(R) Crossing Support Catheter, 035" recalled
Bard Peripheral Vascular is recalling Bard Peripheral Vascular Seeker(R) Crossing Support Catheter, 035", distributed nationwide in the US. The recall was initiated on 16 Apr 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1802-2018
- FDA event ID
- 79896
- Recalling firm
- Bard Peripheral Vascular, Tempe, AZ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Apr 2018
- FDA classified
- 11 May 2018
- Reported
- 23 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 16 Apr 2018 | Recall initiated by company | |
| 11 May 2018 | Classified by FDA | +25 days |
| 23 May 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.035", 150 cm, REF SK15035M. Intended to support a guidewire during access into the vasculature.
Where it was distributed
Nationwide Distribution
Questions about this recall
Is Seeker(R) Crossing Support Catheter, 035" recalled?
Yes. Bard Peripheral Vascular recalled Seeker(R) Crossing Support Catheter, 035" on 16 Apr 2018. The recall is Class II and its status is Terminated. Recall number Z-1802-2018.
Why was it recalled?
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.
Which lots are affected?
UDI: (01)00801741067921(17)191115(10)VTBY0563, Lot Number: VTBY0563
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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