MicroCool Breathable Impervious Gown with Secure Fit Surgical, (Large and X-Large), Made in Hondu...

FDA Device Recall #Z-2018-2012 - Class II, September 17, 2009

Recall Summary

Recall Number Z-2018-2012
Classification Class II - Moderate risk
Date Initiated September 17, 2009
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Kimberly-Clark Corporation
Location Roswell, GA
Product Type Devices

Product Description

MicroCool Breathable Impervious Gown with Secure Fit Surgical, (Large and X-Large), Made in Honduras. The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to be worn by heathcare professionals to help protect the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter.

Reason for Recall

Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns.

Distribution Pattern

Nationwide Distribution including AL, FL, GA, KY, LA, MS, NC, OH, SC, TN, and VA

Lot / Code Information

Product Code: 92354 (Secure-Fit Large), Lot #AH9141 and Product Code: 92355 (Secure Fit X-Large), Lot #AH9143. Customers were notified to include Lot range AH9076xxx to AH9175xxx. On November 17, 2009 the recall was expanded to include the following: Product number: 92354 (Large), Lot number range AH9072xxx to AH9175xxx; Product number: 92355 (X-Large), Lot number: AH9141 and Product number: 92358 (XX-Large), Lot number: AH9173.

Other Recalls from Kimberly-Clark Corporation

Recall # Classification Product Date
Z-0748-2019 Class II U by Kotex¿ Sleek¿, Regular Tampons, 18 Count Dec 11, 2018
Z-0749-2019 Class II U by Kotex¿ Sleek¿, Regular Tampons, 34 Count Dec 11, 2018
Z-0750-2019 Class II U by Kotex¿ Sleek¿, Regular/Super Tampons, 34 C... Dec 11, 2018
Z-0751-2019 Class II U by Kotex¿ Sleek¿, Regular Tampons, 3 Count Dec 11, 2018
Z-0850-2014 Class II Kimberly-Clark RadiOpaque Radiofrequency Cannul... Oct 29, 2013

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.