FDA (Devices) recall action 81108

Stryker Neurovascular recalled 8 products on 2019-11-06

The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2019-11-06
Critical: 0
Units: 49,127

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–8 of 8

ModerateFDA (Devices)··2019-11-06
Stryker Neurovascular Recalls Synchro2 Guidewires Due to Labeling Error
Stryker Neurovascular is recalling Synchro2 guidewires because the product labels contain a typographical error in the millimeter dimension for the outer diameter.
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.
Category
Distribution
51 states
ModerateFDA (Devices)··2019-11-06
Stryker Neurovascular Recalls Synchro2 Guidewires Due to Labeling Error
Stryker Neurovascular is recalling 305 Synchro2 guidewires because the product labels contain a typographical error in the millimeter dimension.
Product
Synchro2, 0.014in x 300cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326520, REF 2652, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
Category
Distribution
51 states
ModerateFDA (Devices)··2019-11-06
Stryker Neurovascular Recalls Synchro2 Guidewires Due to Labeling Error
Stryker Neurovascular is recalling 107 Synchro2 guidewires because the product labels contain a typographical error in the millimeter dimension for the outer diameter.
Product
Synchro2, 0.014in. x 300cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326320, REF 2632, STERILE:EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
Category
Distribution
51 states
LowFDA (Devices)··2019-11-06
Stryker Neurovascular Recalls Synchro2 Guidewires Due to Labeling Error
Stryker Neurovascular is recalling Synchro2 guidewires because the product labels contain a typographical error in the millimeter dimension for the outer diameter.
Product
Synchro2, 0.014in x 300cm STANDARD Guidewire with Hydrophilic Coating UPN Product No. M00326510, REF 2651, STERILE:EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
Category
Distribution
51 states
LowFDA (Devices)··2019-11-06
Stryker Neurovascular Recalls Synchro2 Guidewires Due to Labeling Error
Stryker Neurovascular is recalling Synchro2 guidewires because the product labels contain a typographical error in the millimeter dimension for the outer diameter.
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.
Category
Distribution
51 states
ModerateFDA (Devices)··2019-11-06
Stryker Neurovascular Recalls Synchro2 Guidewires Due to Labeling Error
Stryker Neurovascular is recalling Synchro2 guidewires because the product labels contain a typographical error in the millimeter dimension.
Product
Synchro2, 0.014in x 200cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326110, REF 2611, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
Category
Distribution
51 states
LowFDA (Devices)··2019-11-06
Stryker Neurovascular Recalls Synchro2 Guidewires Due to Labeling Error
Stryker Neurovascular is recalling Synchro2 guidewires because the product labels contain a typographical error in the millimeter dimension for the outer diameter.
Product
Synchro2, 0.014in. x 200cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating UPN Product No. M00326420, REF 2642, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
Category
Distribution
51 states
HighFDA (Devices)··2019-11-06
Stryker Neurovascular Recalls Synchro2 Soft Guidewires for Sterility Concerns
Stryker Neurovascular is recalling 831 units of Synchro2 Soft Guidewires due to a potential loss of sterility. The recall covers units distributed worldwide.
Product
Synchro2, 0.014in x 300cm SOFT Guidewire with Hydrophilic Coating , UPN Product No. M00326310, REF 2631, STERILE:EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
Category
Distribution
51 states