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Terminated

Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102. Intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures.

FDA Recall Z-2400-2012 · Posted 2012-09-17

Recalling FirmVascular Solutions, Inc.
Recall StatusTerminated
Product CodeDTL
Date Initiated2012-08-30
Date Terminated2012-12-04
Product Quantity3500 units

Reason for Recall

Vascular Solutions, Inc., became aware of a potential problem involving pouches missing a seal from Guardian II (Model 8210) and Guardian II NC (Model FH102) Hemostasis Valve which poses a risk of product contamination.

Firm Action

The firm, Vascular Solutions, sent an "URGENT - Medical Device Field Safety Notice" dated August 24, 2012 and a follow-up "Urgent Medical Device Removal - Lot Specific" letter dated August 30, 2012 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately check their inventory and to follow steps outlined in the letter which included to complete and return the "VSI Account Inventory Form" via email to: [email protected] or fax: to (763) 656-4251. If you have specific questions or concerns regarding this matter, please contact your local Vascular Solutions Account Manager; call (763) 656 4300 or email: Senior Regulatory Operations Associate at [email protected] and/or email: www.vascularsolutions.com.

Root Cause

Process control

Distribution Pattern

Worldwide distribution: USA (nationwide) including states of: AZ, AR, CA, CT, DE, FL, GA, ID, IL IN , KY, LA,MD, MN, MO, NV, NM, NY, OH, PA, SC, TN, TX, VA, WA, and WV; and countries of: Italy and Korea. Italy, Korea

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K101113GUARDIAN II NC HEMOSTASIS VALVEZerusa Limited · 2010-05-21K092711GUARDIAN II HEMOSTASIS VALVEZerusa Limited · 2009-10-01

Official Source

View FDA Recall →

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

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