Device product
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.
Z-1466-2021
Product summary
- Event
- Event 87567
- Status
- Terminated
- Classification
- Class II
- Quantity
- 267 kits
- Official record key
device-enforcement:Z-1466-2021
Official wording
Reason: 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.
Code information: UPN: H787CT96STSDVI1, Lot #: 5616651, 5647359, 5654135 UPN: H787CT96STSAVI1, Lot #: 5654129
Distribution pattern: 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.
Derived failure modes
-
Sterility assurance
compromised sterility