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Recall Observatory FDA recall evidence

Device product

AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheters.

Z-1467-2021

February 22, 2021

Class II

Product summary

Firm
Angiodynamics Inc. (Navilyst Medical Inc.)
Event
Event 87567
Status
Terminated
Classification
Class II
Quantity
337 units, (14 boxes of 5, 267 units each kit)
Official record key
device-enforcement:Z-1467-2021

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: VI10, Lot #: DP-11759

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

    reason.sterility_assurance · v1.0.0

    compromised sterility