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

FDA Device Recall #Z-1684-2013 — Class II — May 15, 2013

Recall Summary

Recall Number Z-1684-2013
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 249,576 units

Product Description

Four Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4031 -Approximate Length 99" (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

R08D28039 R08D28047 R08D28054 R08H20094 R08H22124 R08H25010 R08H28113 R08I06083 R08I08097 R08I09087 R08J06124 R08J13088 R08K21139 R08K29074 R08L08092 R08L12110 R09A16013 R09A27101 R09A31079 R09B17043 R09B26010 R09C02084 R09C15029 R09D13089 R09E12120 R09E19133 R09F13068 R09F22028 R09G13108 R09H05037 R09H06134 R09H19111 R09I08096 R09I27013 R09J08038 R09J14010 R09J27103 R09J28119 R09K12129 R09L04017 R09L22035 R10A06011 R10A08165 R10A19113 R10A21655 R10B17024 R10C11033 R10C11116 R10C15026 R10D15081 R10D16063 R10D16154 R10D24067 R10E03035 R10G21108 R10G27089 R10H21064 R10H23110 R10I02138 R10I04068 R10I25071 R10J19123 R10J25096 R10K17984 R10K25094 R10L03065 R10L06019 R10L21174 R11B16165 R11B23161 R11C15165 R11C22229 R11D04084 R11D12038 R11E04115 R11E13066 R11E28072 R11E30086 R11F08171 R11H05041 R11H16071 R11H22053 R11I06039 R11I16095 R11I28249 R11J12093 R11J13158 R11J14081 R11K19054 R11K21183 R12A09070 R12A09112 R12B25058 R12C28142 R12E19070 R12E21076 R12E31125 R12F11109 R12F12081

Other Recalls from Baxter Healthcare Corp.

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Z-0670-2017 Class II sigma spectrum VOLUMETRIC INFUSION PUMP with Ma... Sep 28, 2016
Z-0671-2017 Class II Baxter SIGMA Spectrum INFUSION PUMP with Master... Sep 28, 2016
Z-0672-2017 Class II V6 Rear Case Assembly, Product Code 35701, a re... Sep 28, 2016
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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