| Class 2 Device Recall Synchro 2 Guidewire | |
Date Initiated by Firm | June 08, 2018 |
Date Posted | October 29, 2019 |
Recall Status1 |
Terminated 3 on April 28, 2021 |
Recall Number | Z-0226-2020 |
Recall Event ID |
81108 |
510(K)Number | K190843 |
Product Classification |
Wire, guide, catheter - Product Code DQX
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Product | Synchro2, 0.014in x 200cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326110, REF 2611, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures. |
Code Information |
UPN: M00326110 Lot Numbers/UDI: 0000000562/ (01)04546540688736(17)201031(10)0000000562; 0000001015/ (01)04546540688736(17)201031(10)0000001015; 0000001277/ (01)04546540688736(17)201031(10)0000001277; 0000001288/ (01)04546540688736(17)201031(10)0000001288; 0000001494/ (01)04546540688736(17)201031(10)0000001494; 0000000981/ (01)04546540688736(17)201031(10)0000000981; 0000002055/ (01)04546540688736(17)201130(10)0000002055; 0000002239/ (01)04546540688736(17)201130(10)0000002239; 0000002973/ (01)04546540688736(17)201231(10)0000002973; 0000003130/ (01)04546540688736(17)201231(10)0000003130; 0000003131/ (01)04546540688736(17)201231(10)0000003131; 0000003464/ (01)04546540688736(17)210131(10)0000003464; 0000003949/ (01)04546540688736(17)210131(10)0000003949; 0000003680/ (01)04546540688736(17)200112(10)0000003680; 0000004124/ (01)04546540688736(17)210131(10)0000004124; 0000005456/ (01)04546540688736(17)200227(10)0000005456; 0000005986/ (01)04546540688736(17)210331(10)0000005986; 0000006197/ (01)04546540688736(17)210331(10)0000006197; 0000006198/ (01)04546540688736(17)210331(10)0000006198; 0000006313/ (01)04546540688736(17)210331(10)0000006313; 0000006479/ (01)04546540688736(17)210331(10)0000006479; 0000006968/ (01)04546540688736(17)210407(10)0000006968; 0000007088/ (01)04546540688736(17)210430(10)0000007088; 0000007635/ (01)04546540688736(17)210421(10)0000007635; 0000007423/ (01)04546540688736(17)210430(10)0000007423; 0000007636/ (01)04546540688736(17)210421(10)0000007636; 0000007851/ (01)04546540688736(17)210425(10)0000007851. |
Recalling Firm/ Manufacturer |
Stryker Neurovascular 47900 Bayside Pkwy Fremont CA 94538-6515
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For Additional Information Contact | Geraldine Ahern 510-413-2593 |
Manufacturer Reason for Recall | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error. |
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 | 3720 |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = DQX
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