FDAFDA · Food and drugs·Recall number Z-0504-2020
BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022
Published November 27, 2019 · Recall initiated: September 18, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in a delay to the implantation procedure.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Distributor
- Worldwide distribution - US Nationwide in the state of CA, CT, FL, GA, IA, IN, KS, KY, MI, MO, MS, MT, NE, NJ, NY, OH, OK, OR, PA, TN, TX, WA, WI and country of Canada.
- Lot
- 5478033, 5482424
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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