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U.S. Department of Health and Human Services

Class 2 Device Recall AngioDynamics Safe Sheath Ultralite

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  Class 2 Device Recall AngioDynamics Safe Sheath Ultralite see related information
Date Initiated by Firm February 22, 2021
Create Date April 21, 2021
Recall Status1 Terminated 3 on July 19, 2022
Recall Number Z-1467-2021
Recall Event ID 87567
510(K)Number K122084  
Product Classification Introducer, catheter - Product Code DYB
Product AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer
Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheters.
Code Information UPN: VI10, Lot #: DP-11759
Recalling Firm/
Manufacturer		 Angiodynamics Inc. (Navilyst Medical Inc.)
10 Glens Falls Tech Park
Glens Falls NY 12801-3864
For Additional Information Contact David Greer
518-795-1676
Manufacturer 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.
FDA Determined
Cause 2		 Under Investigation by 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.
Quantity in Commerce 337 units, (14 boxes of 5, 267 units each kit)
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = Oscor Inc.
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