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U.S. Department of Health and Human Services

Class 2 Device Recall Synchro 2 Guidewire

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  Class 2 Device Recall Synchro 2 Guidewire see related information
Date Initiated by Firm June 08, 2018
Date Posted October 29, 2019
Recall Status1 Terminated 3 on April 28, 2021
Recall Number Z-0227-2020
Recall Event ID 81108
510(K)Number K190843  
Product Classification Wire, guide, catheter - Product Code DQX
Product Synchro2, 0.014in x 300cm SOFT Guidewire with Hydrophilic Coating , UPN Product No. M00326310, REF 2631, STERILE:EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
Code Information UPN: M00326310  Lot Numbers/UDI: 0000000563/ (01)04546540688743(17)201031(10)0000000563; 0000000986/ (01)04546540688743(17)201031(10)0000000986; 0000001646/ (01)04546540688743(17)201130(10)0000001646; 0000002238/ (01)04546540688743(17)201130(10)0000002238; 0000002426/ (01)04546540688743(17)201231(10)0000002426; 0000002640/ (01)04546540688743(17)201231(10)0000002640; 0000003465/ (01)04546540688743(17)210131(10)0000003465; 0000004906/ (01)04546540688743(17)210228(10)0000004906; 0000005147/ (01)04546540688743(17)210228(10)0000005147; 0000005343/ (01)04546540688743(17)210228(10)0000005343; 0000007637/ (01)04546540688743(17)210421(10)0000007637; 
Recalling Firm/
Manufacturer		 Stryker Neurovascular
47900 Bayside Pkwy
Fremont CA 94538-6515
For Additional Information Contact Geraldine Ahern
510-413-2593
FDA Determined
Cause 2		 Employee error
Action On 6/08/18, "Urgent Medical Device Voluntary Customer Communication" were mailed via courier. The firm informed its customers that it has become aware that the product label (pouch and carton) for the affected products contain an incorrect value in millimeters (0.036 mm) for the Guidewire Outer Diameter dimension, but there will be no products being recalled. The Customer Notification Letter instructs customers to read this communication carefully and complete the following actions: 1. Immediately check your inventory. 2. Review the Communication and ensure full understanding of the contents. 3. Circulate this Customer Communication internally to all interested/affected parites. 4. Inform the Recalling Firm if any of the subject devices have been distributed to other organizations. 5. Please provide contact details so that the Recalling Firm can inform the recipients appropriately. 6. Please inform the Recalling Firm of any adverse events concening the use of the subject devices. 7. Return the completed form to your nominated Sales Representative of to NVFieldActions@stryker.com. 8. The Recalling Firm is requesting that customers respond to the Customer Communication within 7 calendar days for the date of receipt and a target date for completion of this action is 30 June 2018.
Quantity in Commerce 831
Distribution Worldwide distributions- U.S. Nationwide including the states of AL, AZ, AR, CA, CO, CT, DC, DE, FL, GA, GU, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY. Countries of Austria, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Jordan, Lithuania, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, and UK.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DQX and Original Applicant = Stryker
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