Z-0225-2020Class II

Synchro2, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Product No. M00326010 REF 2601...

Name: Z-0225-2020 Synchro2, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Product No. M00326010 REF 2601...
Creator: Stryker Neurovascular
Published: 2018-06-08
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2018-06-08 / Terminated / root cause: manufacturing process

FDA source

Stryker Neurovascular began a recall of 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... on 2018-06-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0225-2020
Classification: Class II
Status: Terminated
Initiated: 2018-06-08
Posted: 2019-10-29
Terminated: 2021-04-28
Recalling firm: Stryker Corp.
Product: 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.
Product code: DQX Wire, Guide, Catheter
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.
Root cause tag: manufacturing process
FDA root cause: 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 [email protected]. 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: 13503
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.
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0225-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0225-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-29
Z-0226-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-29
Z-0227-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-29
Z-0228-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-29
Z-0229-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-29
Z-0230-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-29
Z-0231-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-29
Z-0232-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-29

Product code DQX

K190843Class IISynchro2 Support GuidewireStryker / cleared 2019-05-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)