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Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product Code 2C4013 - Ap...

FDA Device Recall #Z-1682-2013 — Class II — May 15, 2013

Recall Summary

Recall Number Z-1682-2013
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 356,728 units

Product Description

Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product Code 2C4013 - Approximate Length 85" (2.2. 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

UR175554 UR176743 UR182030 UR188144 UR192047 UR192096 UR192260 UR194951 UR202044 UR204032 UR211698 UR214312 UR216069 UR222471 UR225334 UR229294 UR233569 UR233700 UR238915 UR243022 UR246009 UR249383 UR255802 UR260273 UR262980 UR263004 UR265918 UR283580 UR287284 UR288746 UR298216 UR304246 UR307249 UR314328 UR318063 UR321000 UR325464 UR334151 UR339317 UR344234 UR352484 UR352567 UR360255 UR363432 UR366161 UR375857 UR383794 UR385534 UR07J19029 UR07K29059 UR07L21039 UR08B21053 UR08C25151 UR08E15157 UR08G22167 UR08I12065 UR08K13086 UR08L18158 UR09A21211 UR09D02157 UR09E14084 UR09G17125 UR09H26140 UR09J30040 UR09J30065 UR09J30107 UR09L01146 UR10C25033 UR10D09142 UR10E21037 UR10G28129 UR10I28034 UR10L03024 UR10L22024 UR11A14022 UR11B24086 UR11B25125 UR11C25032 UR11F01028 UR11G08088 UR11H08011 UR11H09019 UR11I08043 UR11I23026 UR12A25043 UR12E18502 UR12H03011 UR12H17045 UR12I05030 UR12I06053 UR12I21052 UR12J18040 UR12J26019 UR12L12023 UR13B08053 UR13B15041 UR13C08036

Other Recalls from Baxter Healthcare Corp.

Recall # Classification Product Date
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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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