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Angiodynamics Inc. (Navilyst Medical Inc.) Recall: BIOFLO 8F SINGLE TITANIUM NON- FILLED;

Angiodynamics Inc. (Navilyst Medical Inc.) Recall: BIOFLO 8F SINGLE TITANIUM NON- FILLED; is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Angiodynamics Inc. (Navilyst Medical Inc.); Product: BIOFLO 8F SINGLE TITANIUM NON- FILLED; VALVED, UPN H965440250, Cat. No. 44-025 - Product Usage:

Recalling firmAngiodynamics Inc. (Navilyst Medical Inc.)
ProductBIOFLO 8F SINGLE TITANIUM NON- FILLED; VALVED, UPN H965440250, Cat. No. 44-025 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.
Reason for recallSnap 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.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionWorldwide 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.
Recall initiated20190918
Recall numberZ-0502-2020
Categorydevice
StateNY
CountryUnited States

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