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.
FDA Recall Z-1466-2021 · Posted None
Advertisement
Recalling FirmAngiodynamics Inc. (Navilyst Medical Inc.)
Recall StatusTerminated
Product CodeLJT
Date Initiated2021-02-22
Date Terminated2022-07-19
Product Quantity267 kits
Reason for Recall
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.
Firm Action
On 2/22/2021, AngioDynamics issued an Urgent Medical Device Recall notice via letter informing customers the package integrity of specific Valved Introducers may be susceptible to failure, resulting in the potential for compromised sterility of the device.
Root Cause
Under Investigation by firm
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement