Z-0225-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 6, 2019
- Initiation Date
- June 8, 2018
- Termination Date
- April 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13503
Product Description
Synchro2, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Product No. M00326010 REF 2601, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
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.
Distribution Pattern
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.
Code Information
UPN: M00326010 Lot Numbers/UDI:0000000558 /(01)04546540688729(17)201031(10)0000000558; 0000000560/ (01)04546540688729(17)201031(10)0000000560; 0000000671/ (01)04546540688729(17)201031(10)0000000671; 0000000672/ (01)04546540688729(17)201031(10)0000000672; 0000000980/ (01)04546540688729(17)201031(10)0000000980; 0000000987/ (01)04546540688729(17)201031(10)0000000987; 0000001013/ (01)04546540688729(17)201031(10)0000001013; 0000001014/ (01)04546540688729(17)201031(10)0000001014; 0000001275/ (01)04546540688729(17)201031(10)0000001275; 0000001274/ (01)04546540688729(17)201031(10)0000001274; 0000001276/ (01)04546540688729(17)201031(10)0000001276; 0000001287/ (01)04546540688729(17)201031(10)0000001287; 0000001285/ (01)04546540688729(17)201031(10)0000001285; 0000001492/ (01)04546540688729(17)201031(10)0000001492; 0000001286/ (01)04546540688729(17)201031(10)0000001286; 0000001493/ (01)04546540688729(17)201031(10)0000001493; 0000001909/ (01)04546540688729(17)201130(10)0000001909; 0000001910/ (01)04546540688729(17)201130(10)0000001910; 0000002053/ (01)04546540688729(17)201130(10)0000002053; 0000002054/ (01)04546540688729(17)201130(10)0000002054; 0000002425/ (01)04546540688729(17)201231(10)0000002425; 0000002639/ (01)04546540688729(17)201231(10)0000002639; 0000002638/ (01)04546540688729(17)201231(10)0000002638; B47912/ (01)04546540688729(17)200930(10)B47912; 0000002764/ (01)04546540688729(17)201231(10)0000002764; 0000002765/ (01)04546540688729(17)201231(10)0000002765; 0000003120/ (01)04546540688729(17)201231(10)0000003120; 0000003463/ (01)04546540688729(17)210131(10)0000003463; 0000003458/ (01)04546540688729(17)210131(10)0000003458; 0000003462/ (01)04546540688729(17)210131(10)0000003462; 0000003593/ (01)04546540688729(17)210109(10)0000003593; 0000003946/ (01)04546540688729(17)210131(10)0000003946; 0000003461/ (01)04546540688729(17)210131(10)0000003461; 0000003460/ (01)04546540688729(17)210131(10)0000003460; 0000003947/ (01)04546540688729(17)210131(10)0000003947; 0000003948/ (01)04546540688729(17)210131(10)0000003948; 0000003679/ (01)04546540688729(17)210111(10)0000003679; 0000004122/ (01)04546540688729(17)210131(10)0000004122; 0000004123/ (01)04546540688729(17)210131(10)0000004123; 0000004356/ (01)04546540688729(17)210131(10)0000004356; 0000004357/ (01)04546540688729(17)210131(10)0000004357; 0000004359/ (01)04546540688729(17)210131(10)0000004359; 0000004360/ (01)04546540688729(17)210131(10)0000004360; 0000004358/ (01)04546540688729(17)210131(10)0000004358; 0000004639/ (01)04546540688729(17)210228(10)0000004639; 0000004642/ (01)04546540688729(17)210228(10)0000004642; 0000004640/ (01)04546540688729(17)210228(10)0000004640; 0000004905/ (01)04546540688729(17)210228(10)0000004905; 0000004998/ (01)04546540688729(17)210214(10)0000004998; 0000005342/ (01)04546540688729(17)210228(10)0000005342; 0000005270/ (01)04546540688729(17)210222(10)0000005270; 0000005534/ (01)04546540688729(17)210331(10)0000005534; 0000005536/ (01)04546540688729(17)210331(10)0000005536; 0000005535/ (01)04546540688729(17)210331(10)0000005535; 0000005537/ (01)04546540688729(17)210331(10)0000005537; 0000005850/ (01)04546540688729(17)210331(10)0000005850; 0000005851/ (01)04546540688729(17)210331(10)0000005851; 0000006312/ (01)04546540688729(17)210331(10)0000006312; 0000006431/ (01)04546540688729(17)210321(10)0000006431; 0000006465/ (01)04546540688729(17)210322(10)0000006465; 0000006477/ (01)04546540688729(17)210331(10)0000006477; 0000006478/ (01)04546540688729(17)210331(10)0000006478; 0000006925/ (01)04546540688729(17)210402(10)0000006925; 0000006616/ (01)04546540688729(17)210331(10)0000006616; 0000006950/ (01)04546540688729(17)210404(10)0000006950; 0000006997/ (01)04546540688729(17)210430(10)0000006997; 0000007313/ (01)04546540688729(17)210430(10)0000007313; 0000007314/ (01)04546540688729(17)210430(10)0000007314; 0000007417/ (01)04546540688729(17)210430(10)0000007417; 0000007422/ (01)04546540688729(17)210430(10)0000007422;