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Terminated

Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass. Model numbers: FH101, FH101-T, FH101-25, FH101-50, 8210, 8211, FH102, FH102-T, FH102-25, FH102-50, 8215, 8216, 8241, 8242, 8244, 8272 and 8274. Vascular Solutions Zerusa Limited. Intended to maintain hemostasis during the use of diagnostic/interventional devices during diagnostic/interventional procedures.

FDA Recall Z-0955-2013 · Posted 2013-03-20

Recalling FirmVascular Solutions, Inc.
Recall StatusTerminated
Product CodeDTL
Date Initiated2013-02-27
Date Terminated2013-08-05
Product Quantity79,869

Reason for Recall

Risk that air may be introduced into the device which may lead to an air embolism.

Firm Action

Consignees were sent a Vascular Solutions "Urgent Medical Device Recall" letter dated February 28, 2013. The letter described the problem and the product involved in the recall. In addition, consignees were advised to identify the location of and immediately remove the recalled product from their inventory and secure it. Consignees were requested to complete and return the VSI Account Inventory Form. The letter also stated that VSI Customer Service would contact customers within 1-2 business days after receiving the completed VSI Account Inventory Form. All returned affected product will be replaced upon receipt. Customers are to contact their local Sales Representative if they have any questions or concerns regarding this recall.

Root Cause

Vendor change control

Distribution Pattern

Worldwide Distribution -- USA, including the states of AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, IL IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NJ, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT , VT, VA, WA, WV, and WI, and countries of GREECE, DENMARK, AUSTRIA, UNITED KINGDOM, SWITZERLAND, IRELAND, INDIA, TURKEY, POLAND, HUNGARY, ITALY, EGYPT, KOREA, PORTUGAL HONG KONG, GERMANY, SPAIN, MEXICO, SWEDEN, NORWAY SLOVENIA, NETHERLANDS, and BELGIUM.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K122301GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVEVascular Solutions Zerusa , Ltd. · 2012-09-07K101113GUARDIAN 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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