Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requiring repeated access of the vascular system, for delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood and power injection of contrast media for imaging.
Enforcement
- Recall Number
- Z-1466-2021
- Event ID
- 87567
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 28, 2021
- Initiation Date
- February 22, 2021
- Classification Date
- April 21, 2021
- Termination Date
- July 19, 2022
- Address
- 10 Glens Falls Tech Park, N/A, Glens Falls, NY, 12801-3864, United States
Description
Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requiring repeated access of the vascular system, for delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood and power injection of contrast media for imaging.
AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers that may have potential for compromised sterility of the device. Only the specific product/lot of the kit identified below is affected by this recall action. The Product Description, Product Number, Ref./Catalog Number and Batch/Lot number is provided below. No other products are affected by this recall.
UPN: H787CT96STSDVI1, Lot #: 5616651, 5647359, 5654135 UPN: H787CT96STSAVI1, Lot #: 5654129
US Nationwide distribution in the states of AR, CA, CO, FL, HI, IL, IN, KS, MI, MO, NC, ND, NM, NY, OH, OR, PA, SC, TN, TX, VA, WA.
267 kits