Z-0504-2020 Class II Terminated
FDA device recall Z-0504-2020 was initiated by Angiodynamics Inc. (Navilyst Medical Inc.) on September 18, 2019 and is designated Class II. Reason for recall: 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 cha… The recall status is terminated (terminated September 24, 2020). Affected quantity: 582.
Recall Details
- Product Type
- Devices
- Report Date
- November 27, 2019
- Initiation Date
- September 18, 2019
- Termination Date
- September 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 582
Product Description
BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022
Reason for Recall
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.
Distribution Pattern
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.
Code Information
5478033, 5482424