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INCISION & DRAINAGE TRAY or KIT

FDA Device Recall #Z-1088-2018 — Class II — October 23, 2017

Recall Summary

Recall Number Z-1088-2018
Classification Class II — Moderate risk
Date Initiated October 23, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Centurion Medical Products Corporation
Location Williamston, MI
Product Type Devices
Quantity N/A

Product Description

INCISION & DRAINAGE TRAY or KIT

Reason for Recall

Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.

Distribution Pattern

Nationally

Lot / Code Information

ID1090 ID1485 ID1525 ID1595 ID510 ID525 ID580 ID600 ID800 ID875 ID975 Lot codes: 2015102190 2016010790 2016020890 2016022390 2016061090 2016071990 2016101290 2016110390 2017011990 2016121690 2017022390 2017052690 2015101490 2016060690 2016070890 2016102490 2017032190 2017052390 2015091790 2015111990 2015112590 2016070890 2016072790 2016082390 2017020290 2017032890 2017052690 2017030390 2015092490 2015121490 2016010690 2016033190 2016042790 2016052490 2016061390 2016102790 2016112490 2017042890 2017063090 2017071990 2015100890 2017072890 2017040690 2016092290 2016031790 2016012190 2017030290 2016021890 2016060890 2016070790 2016080590 2016111190 2017010990 2017051190 2015110590 2015103090 2016071490 2015121590 2016031590 2016042090 2016051890 2016052590 2016062190 2016110190 2017010390 2017020890 2017040490 2017060890 2017062890 2017082290 2016112290 2016042790 2017060890 2017070790 2017082490 2015101590 2016022590 2016072890 2016090290 2017011190 2017040690 2017061690 2017081190 2017011690 2015092490 2015100890 2015111990 2016040690 2016060890 2016071890 2017013090 2016030790 2016031590 2016080190 2017010390 2017050490 2016072090 2015081190 2015102790 2016010490 2016022490 2016031190 2016060690 2016082990 2016111790 2017011790 2017032890 2017060790 2017071290 2016011590 2016062390 2016062890

Other Recalls from Centurion Medical Products Corporation

Recall # Classification Product Date
Z-1047-2020 Class II Centurion- Dressing Change Tray DT10290S CENTR... Dec 11, 2019
Z-1091-2020 Class II Centurion- ENT SNUF3 SNUFFER KIT Y Dec 11, 2019
Z-1063-2020 Class II Centurion-LVAD Kits DM1005 DAILY LVAD MAINTENA... Dec 11, 2019
Z-1090-2020 Class II Centurion- Skin Prep Kits SB1280 SKIN SCRUB KI... Dec 11, 2019
Z-1058-2020 Class II Centurion- Umbilical Trays UVT1045 UMBILICAL A... Dec 11, 2019

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

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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