Synchro2 recall
Synchro2, 0.014in x 200cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326110, REF 2611, STERILE: EO - Product Usage…
Why was Synchro2 recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Synchro2, 0.014in x 200cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326110, REF 2611, STERILE: EO - Product Usage…
- Recalling firm
- Stryker Neurovascular
- Quantity
- 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.
- Recall date
- November 6, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)