Stryker brand COMPLIANT 4MM X 10MM, Catalog Number: M003SRC04100; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-...
Reason: Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.
Z-0505-2014December 25, 2013Fremont, CA
Stryker Neurovascular
Class IITerminated
Stryker brand GDC-18 360 18MM X 30CM, Catalog Number: M00334818300; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior ...
Reason: Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.
Z-0503-2014December 25, 2013Fremont, CA
Stryker Neurovascular
Class IITerminated
Stryker brand EXCELSIOR SL-10 PRE-SHAPED S 15OCM; Catalog Number: M0031441920; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA E...
Reason: Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.
Z-0497-2014December 25, 2013Fremont, CA
Stryker Neurovascular
Class IITerminated
Stryker brand EXCELSIOR SL-10 PRE-SHAPED 45 150CM, Catalog Number: M0031681900, Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA ...
Reason: Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.
Z-0499-2014December 25, 2013Fremont, CA
Stryker Neurovascular
Class IITerminated
Stryker brand SUPER COMPLIANT 7MM X 15MM, Catalog Number: M003SSC07150; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excels...
Reason: Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.
Z-0512-2014December 25, 2013Fremont, CA
Stryker Neurovascular
Class IITerminated
Stryker brand COMPLIANT 5MM X 15MM, Catalog Number: M003SRC05150; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsio...
Reason: Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.
Z-0509-2014December 25, 2013Fremont, CA
Stryker Neurovascular
Class IITerminated
Stryker brand COMPLIANT 4MM X 20MM, Catalog Number: M003SRC04200; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-...
Reason: Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.
Z-0507-2014December 25, 2013Fremont, CA
Stryker Neurovascular
Class IITerminated
Stryker brand EXCELSIOR SL-10 PRE-SHAPED J 15OCM, Catalog Number: M0031681920; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA E...
Reason: Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.
Z-0501-2014December 25, 2013Fremont, CA
Stryker Neurovascular
Class IITerminated
Stryker brand GDC-10 ULTRA SOFT 2MM X 3CM, Catalog Number: M0033432030; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excels...
Reason: Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.
Z-0502-2014December 25, 2013Fremont, CA
Stryker Neurovascular
Class IITerminated
Stryker brand SUPER COMPLIANT 4MM X 7MM, Catalog Number: M003SSC04070; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsi...
Reason: Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.
Z-0511-2014December 25, 2013Fremont, CA
Stryker Neurovascular
Class IITerminated
Stryker brand EXCELSIOR SL-10 PRE-SHAPED 90 150CM, Catalog Number: M0031681910; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA ...
Reason: Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.
Z-0500-2014December 25, 2013Fremont, CA
Stryker Neurovascular
Class IITerminated
Stryker brand COMPLIANT 4MM X 15MM, Catalog Number: M003SRC04150; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Excelsior SL-10/Excelsior 1018 Microcatheter: Str...
Reason: Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.
Z-0506-2014December 25, 2013Fremont, CA
Stryker Neurovascular
Class IITerminated
Stryker brand COMPLIANT 5MM X 30MM, Catalog Number: M003SRC05300; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL...
Reason: Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.
Z-0510-2014December 25, 2013Fremont, CA
Stryker Neurovascular
Class IITerminated
Stryker brand EXCELSIOR 1018 PRE-SHAPED 45 150CM, Catalog Number: M0031441900; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA E...
Reason: Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.
Z-0494-2014December 25, 2013Fremont, CA
Stryker Neurovascular
Class IITerminated
Stryker brand COMPLIANT 4MM X 30MM, Catalog Number: M003SRC04300; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-...
Reason: Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.
Z-0508-2014December 25, 2013Fremont, CA
Arrow International Inc
Class IITerminated
Continuous Peripheral Nerve Block Catheter Kit and Set Continuous Peripheral Nerve Block Catheter Kit and Set permits placement of catheters next to nerves and nerve plexuses for continuous nerve b...
Reason: A labeling inconsistency was discovered in which the lidstock states that the kit contains a stimulator cable with 1.5mm socket, however, the kit contains a stimulator cable with 1...
Z-0546-2014December 25, 2013Reading, PA
Stryker Neurovascular
Class IITerminated
Stryker brand GDC VORTX 2MM X 3MM, Catalog Number: M00335302340; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-1...
Reason: Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.
Z-0504-2014December 25, 2013Fremont, CA
Stryker Neurovascular
Class IITerminated
Stryker brand EXCELSIOR SL-10 PRE-SHAPED C 15OCM; Catalog Number: M0031441940; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA E...
Reason: Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.
Z-0496-2014December 25, 2013Fremont, CA
Stryker Neurovascular
Class IITerminated
Stryker brand EXCELSIOR SL-10 PRE-SHAPED J 15OCM; Catalog Number: M0031441930; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA E...
Reason: Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.
Z-0495-2014December 25, 2013Fremont, CA
Stryker Neurovascular
Class IITerminated
Stryker brand EXCELSIOR SL-10 150CM 2 TIP, Catalog Number: M0031681890, Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excels...
Reason: Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.
Z-0498-2014December 25, 2013Fremont, CA
CareFusion 303, Inc.
Class IITerminated
SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 24301-0007T The SmartSite Low Sorbing Infusion Sets with Texium Male Luer are used to administer fluid and medications thro...
Reason: CareFusion is recalling the SmartSite Low Sorbing Infusion Set with Texium Closed Male Luer because it is not assembled with low-sorbing tubing.
Z-0450-2014December 11, 2013San Diego, CA
Stryker Sustainability Solutions
Class IITerminated
Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Catheter Cables, Model Numbers: D6-DR-252-RT, F6-QF-252RT, 201101, 201104, 401442, 401860, D7-A20-131-RT, 401661, 401972, 4019...
Reason: Stryker Sustainability Solutions is recalling the Reprocessed Diagnostic Electrophysiology (EP) Catheters Cables due to a potential sterility breach in the package seal.
Z-0340-2014November 27, 2013Tempe, AZ
St. Jude Medical
Class IITerminated
Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx only, Sterile EO. Intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ...
Reason: St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary notification regarding selected batched of Safire Duo Ablation Catheter MediGuide Enabl...
Z-0187-2014November 20, 2013Plymouth, MN
Baylis Medical Corp *
Class ITerminated
Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three c...
Reason: The TorFlex Transseptal Guiding Sheath Kits are being recalled due to the possibility that the sheath could remove particulate of less than 5 mm from the dilator. The particulate c...
Z-0085-2014November 13, 2013Montreal, N/A
St. Jude Medical
Class IITerminated
US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path Duo Ablation Catheter, MediGuide Enabled REF A700244, Rx only, Sterile EO. The catheters are intended for use with a co...
Reason: St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary notification regarding selected batches of Coolpath Duo Ablation Catheter MediGuide Ena...