Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102. Intended to maintain hemostas

FDA device recall Z-2400-2012 · posted 2012-09-17 · Terminated

Recall details

Recalling firm

Vascular Solutions, Inc.

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.

Action taken

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: customerservice@vasc.com 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 SOuellette@vasc.com and/or email: www.vascularsolutions.com.

Root cause

Process control

Status

Terminated

Product code

DTL

Quantity affected

3500 units

Distribution

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 Kor

Date initiated

2012-08-30

Date posted

2012-09-17

Date terminated

2012-12-04

Location

Maple Grove, MN

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