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Two Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2...

FDA Device Recall #Z-1683-2013 — Class II — May 15, 2013

Recall Summary

Recall Number Z-1683-2013
Classification Class II — Moderate risk
Date Initiated May 15, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Baxter Healthcare Corp.
Location Deerfield, IL
Product Type Devices
Quantity 530,488 units

Product Description

Two Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4030 - Approximate Length 98" (2.5. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cytoscopy, transurethral resection and arthroscopic procedures. the sets are intended for use with Baxter irrigating solutions in Uromatic or Arthromatic plastic containers.

Reason for Recall

A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.

Distribution Pattern

US Nationwide Distribution

Lot / Code Information

R06K01067 R06K01075 R06K01083 R07B02013 R07C14065 R07C22035 R07D19088 R07E07015 R07E20935 R07E29050 R07F02063 R07F05025 R07I22065 R07J01019 R07J28012 R07L05073 R08A14027 R08A28019 R08B04026 R08B05031 R08C18040 R08C24022 R08D12066 R08D15085 R08F28075 R08G19122 R08G21029 R08G21037 R08H21019 R08H27065 R08I20076 R08J10175 R08K04010 R08L05205 R09A17060 R09A28109 R09B16086 R09C16100 R09C30119 R09D14012 R09E19026 R09E25122 R09F10148 R09F16087 R09G14072 R09G27025 R09H27080 R09I28094 R09J13103 R09K11154 R09K30014 R09L09032 R09L16227 R10A08264 R10A19188 R10A21630 R10B13122 R10B16158 R10C10118 R10C13096 R10C24044 R10C27179 R10D05041 R10D26047 R10E11087 R10F05152 R10F19054 R10G27014 R10H17211 R10H31212 R10I01106 R10I07129 R10I27036 R10J19024 R10J19149 R10J23067 R10K02226 R10K13066 R10K25029 R10L04071 R10L23048 R11A11010 R11A15078 R11A31224 R11B07172 R11C01223 R11C15157 R11C22294 R11D04167 R11D16062 R11E12159 R11E21077 R11F24103 R11G18020 R11G18103 R11G19077 R11J24189 R11K22140 R11L22114 R12A04113 R12A11134 R12A23113 R12A31124 R12B15117 R12B27070 R12C08144 R12E17116 R12E18056 R12F07057 R12F09087 R12F11067

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Z-2533-2016 Class II Synovis VASCU-GUARD Peripheral Vascular Patch i... Jun 24, 2016

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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