Bard Peripheral Vascular recalls Seeker Crossing Support Catheters (0.035" x 150cm) due to potential bacterial endotoxin cross-contamination in packaging. Affected units have UDI (01)00801741067921(17)191115(10)VTBY0563. Contact for remedy.
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.
Bard Peripheral Vascular is recalling a specific type of catheter used in medical procedures because packaging hoops might contain bacterial endotoxins that could cross-contaminate during clinical use. This risk is for healthcare professionals using the catheter in medical settings, not for general consumers.
The catheter packaging hoops may have detectable bacterial endotoxins that could cross-contaminate medical equipment during clinical use. This is a potential risk in healthcare settings but does not pose a direct threat to patients or the general public.
Healthcare professionals using the specific catheter model in medical procedures. Patients are not at risk as the catheter is used by medical staff only.
Check for the model: 0.035" x 150 cm, reference number SK15035M. Look for the unique identifier UDI: (01)00801741067921(17)191115(10)VTBY0563 and lot number VTBY0563 on the packaging.
Verify the unique identifier (UDI) and lot number on the packaging to confirm if the catheter is affected.
No, this catheter is intended for use by healthcare professionals only in medical procedures, not for direct patient use.
The risk is low as bacterial endotoxins are detectable but within acceptable levels; cross-contamination could occur in clinical settings but does not cause serious injury.
Check for the model 0.035" x 150 cm, reference SK15035M, and unique identifier UDI: (01)00801741067921(17)191115(10)VTBY0563 with lot number VTBY0563.
We’ve drafted a message you can send Bard Peripheral Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1802-2018 — Bard Peripheral Vascular Bard Peripheral Vascular Hello, I own a Bard Peripheral Vascular that is covered by recall Z-1802-2018 from Bard Peripheral Vascular. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
