Stryker Neurovascular recalls Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophili
Recalled Product
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.
Hazard / Issue
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.
Issued by
FDA
Distribution: Nationwide (United States)
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.
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