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Terminated

VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to ANY 5mm spot suction/irrigation catheter

FDA Recall Z-2237-2019 · Posted None

Recalling FirmSantanello Surgical LLC
Recall StatusTerminated
Product CodeJOL
Date Initiated2019-06-10
Date Terminated2021-01-13
Product Quantity98

Reason for Recall

Lack of package integrity may compromise sterility

Firm Action

Santanello Surgical issued recall letter dated 6/10/19 stating reason for recall, health risk and action to take: immediately examine inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Email [email protected] for return shipment procedures and reimbursement process. Questions call Santanello Surgical at 614-955-1832.

Root Cause

Package design/selection

Distribution Pattern

FL,OK, OH, NY, ME, MN, WI

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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