Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201 AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.
FDA Recall Z-0742-2018 · Posted 2018-02-13
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Recalling FirmAngiodynamics, Inc.
Recall StatusTerminated
Product CodeDQO
Date Initiated2017-09-22
Date Terminated2018-09-19
Product Quantity28
Reason for Recall
Product was placed into distribution prior to completion of all required post sterilization release activities.
Firm Action
Consignees were contacted by phone and by a letter sent via Federal Express. Consignees were instructed to stop using product, segregate affected product, and return the product to the firm along with a reply verification tracking form.
For further questions, please call (518) 795-1676.
Root Cause
Process control
Distribution Pattern
US Distribution to the states of : AL, CA, CT, FL, GA, IL, IN, MD, MI, MN, MO, OH, OR, TX.
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.
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