Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating, UPN Product No. M00326410, REF 2641, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
This recall has been terminated (originally issued October 29, 2019).
- Company
- Stryker Neurovascular
- Recall Initiated
- June 8, 2018
- Posted
- October 29, 2019
- Terminated
- April 28, 2021
- Recall Number
- Z-0229-2020
- Quantity
- 21971
- Firm Location
- Fremont, CA
- Official Source
- View on FDA website ↗
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
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.
Lot / Code Info
UPN: M00326410 Lot Numbers/UDI:0000000564/ (01)04546540688767(17)201031(10) 0000000564; 0000000565/ (01)04546540688767(17)201031(10)0000000565; 0000000566/(01)04546540688767(17)201031(10)0000000566; 0000000673/ (01)04546540688767(17)201031(10)0000000673; 0000000674/ (01)04546540688767(17)201031(10)0000000674; 0000000675/ (01)04546540688767(17)201031(10)0000000675; 0000000983/ (01)04546540688767(17)201031(10)0000000983; 0000000982/ (01)04546540688767(17)201031(10)0000000982; 0000001016/ (01)04546540688767(17)201031(10)0000001016; 0000001017/ (01)04546540688767(17)201031(10)0000001017; 0000001018/ (01)04546540688767(17)201031(10)0000001018; 0000001280/ (01)04546540688767(17)201031(10)0000001280; 0000001279/ (01)04546540688767(17)201031(10)0000001279; 0000001278/ (01)04546540688767(17)201031(10)0000001278; 0000001289/ (01)04546540688767(17)201031(10)0000001289; 0000001290/ (01)04546540688767(17)201031(10)0000001290; 0000001291/ (01)04546540688767(17)201031(10)0000001291; 0000001495/ (01)04546540688767(17)201031(10)0000001495; 0000001497/ (01)04546540688767(17)201031(10)0000001497; 0000001496/ (01)04546540688767(17)201031(10)0000001496; 0000001640/ (01)04546540688767(17)201130(10)0000001640; 0000001641/ (01)04546540688767(17)201130(10)0000001641; 0000001642/ (01)04546540688767(17)201130(10)0000001642; 0000000989/ (01)04546540688767(17)201031(10)0000000989; 0000001912/ (01)04546540688767(17)201130(10)0000001912; 0000001913/ (01)04546540688767(17)201130(10)0000001913; 0000001914/ (01)04546540688767(17)201130(10)0000001914; 0000001643/ (01)04546540688767(17)201130(10)0000001643; 0000002056/ (01)04546540688767(17)201130(10)0000002056; 0000002057/ (01)04546540688767(17)201130(10)0000002057; 0000002058/ (01)04546540688767(17)201130(10)0000002058; 0000002236/ (01)04546540688767(17)201130(10)0000002236; 0000002235/ (01)04546540688767(17)201130(10)0000002235; 0000002233/ (01)04546540688767(17)201130(10)0000002233; 0000002234/ (01)04546540688767(17)201130(10)0000002234; 0000002427/ (01)04546540688767(17)201231(10)0000002427; 0000002428/ (01)04546540688767(17)201231(10)0000002428; 0000002429/ (01)04546540688767(17)201231(10)0000002429; 0000002430/ (01)04546540688767(17)201231(10)0000002430; 0000002642/ (01)04546540688767(17)201231(10)0000002642; 0000002641/ (01)04546540688767(17)201231(10)0000002641; 0000002643/ (01)04546540688767(17)201231(10)0000002643; 0000002644/ (01)04546540688767(17)201231(10)0000002644; 0000002766/ (01)04546540688767(17)201231(10)0000002766; 0000002767/ (01)04546540688767(17)201231(10)0000002767; 0000002768/ (01)04546540688767(17)201231(10)0000002768; 0000002974/ (01)04546540688767(17)201231(10)0000002974; 0000002975/ (01)04546540688767(17)201231(10)0000002975; 0000002976/ (01)04546540688767(17)201231(10)0000002976; 0000003768/ (01)04546540688767(17)210131(10)0000003768; 0000003767/ (01)04546540688767(17)210131(10)0000003767; 0000003769/ (01)04546540688767(17)210131(10)0000003769; 0000003770/ (01)04546540688767(17)210131(10)0000003770; 0000003950/ (01)04546540688767(17)210131(10)0000003950; 0000004126/ (01)04546540688767(17)210131(10)0000004126; 0000004125/ (01)04546540688767(17)210131(10)0000004125; 0000004111/ (01)04546540688767(17)200124(10)0000004111; 0000004321/ (01)04546540688767(17)200130(10)0000004321; 0000004597/ (01)04546540688767(17)200205(10)0000004597; 0000004899/ (01)04546540688767(17)210228(10)0000004899; 0000004900/ (01)04546540688767(17)210228(10)0000004900; 0000004901/ (01)04546540688767(17)210228(10)0000004901; 0000005142/ (01)04546540688767(17)210228(10)0000005142; 0000005144/ (01)04546540688767(17)210228(10)0000005144; 0000005145/ (01)04546540688767(17)210228(10)0000005145; 0000005146/ (01)04546540688767(17)210228(10)0000005146; 0000005148/ (01)04546540688767(17)210228(10)0000005148; 0000005344/ (01)04546540688767(17)210228(10)0000005344; 0000005346/ (01)04546540688767(17)210228(10)0000005346; 0000005345/ (01)04546540688767(17)210228(10)0000005345; 0000005347/ (01)04546540688767(17)210228(10)0000005347; 0000005348/ (01)04546540688767(17)210228(10)0000005348; 0000005532/ (01)04546540688767(17)210331(10)0000005532; 0000005533/ (01)04546540688767(17)210331(10)0000005533; 0000005531/ (01)04546540688767(17)200301(10)0000005531; 0000005687/ (01)04546540688767(17)200305(10)0000005687; 0000005828/ (01)04546540688767(17)200307(10)0000005828; 0000004902/ (01)04546540688767(17)210228(10)0000004902; 0000004903/ (01)04546540688767(17)210228(10)0000004903; 0000005852/ (01)04546540688767(17)210331(10)0000005852; 0000005853/ (01)04546540688767(17)210331(10)0000005853; 0000005987/ (01)04546540688767(17)210331(10)0000005987; 0000005988/ (01)04546540688767(17)210331(10)0000005988; 0000005989/ (01)04546540688767(17)210331(10)0000005989; 0000006199/ (01)04546540688767(17)210331(10)0000006199; 0000006200/ (01)04546540688767(17)210331(10)0000006200; 0000006316/ (01)04546540688767(17)210331(10)0000006316; 0000006315/ (01)04546540688767(17)210331(10)0000006315; 0000006314/ (01)04546540688767(17)210331(10)0000006314; 0000006601/ (01)04546540688767(17)210325(10)0000006601; 0000006672/ (01)04546540688767(17)210326(10)0000006672; 0000006482/ (01)04546540688767(17)210331(10)0000006482; 0000006480/ (01)04546540688767(17)210331(10)0000006480; 0000006481/ (01)04546540688767(17)210331(10)0000006481; 0000006827/ (01)04546540688767(17)210401(10)0000006827; 0000006619/ (01)04546540688767(17)210331(10)0000006619; 0000006618/ (01)04546540688767(17)210331(10)0000006618; 0000006620/ (01)04546540688767(17)210331(10)0000006620; 0000007032/ (01)04546540688767(17)210407(10)0000007032; 0000007001/ (01)04546540688767(17)210430(10)0000007001; 0000006999/ (01)04546540688767(17)210430(10)0000006999; 0000007000/ (01)04546540688767(17)210430(10)0000007000; 0000007174/ (01)04546540688767(17)210410(10)0000007174; 0000007082/ (01)04546540688767(17)210408(10)0000007082; 0000007089/ (01)04546540688767(17)210430(10)0000007089; 0000007090/ (01)04546540688767(17)210430(10)0000007090; 0000007091/ (01)04546540688767(17)210430(10)0000007091; 0000007092/ (01)04546540688767(17)210410(10)0000007092; 0000007315/ (01)04546540688767(17)210430(10)0000007315; 0000007317/ (01)04546540688767(17)210430(10)0000007317; 0000007316/ (01)04546540688767(17)210430(10)0000007316; 0000007426/ (01)04546540688767(17)210430(10)0000007426; 0000007425/ (01)04546540688767(17)210430(10)0000007425; 0000007741/ (01)04546540688767(17)210422(10)0000007741; 0000007771/ (01)04546540688767(17)210423(10)0000007771; 0000007772/ (01)04546540688767(17)210423(10)0000007772; 0000009017.
Root Cause
Employee error
Action Taken
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.