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
Product summary
- 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
compromised sterility