Z-2018-2012Class II

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

Name: Z-2018-2012 MicroCool Breathable Impervious Gown with Secure Fit Surgical, (Large and X-Large), Made in Honduras. The...
Creator: Kimberly-Clark Corporation
Published: 2009-09-17
License: https://open.fda.gov/license/

Kimberly-Clark Corporation / initiated 2009-09-17 / Terminated / root cause: manufacturing process

FDA source

Kimberly-Clark Corporation began a recall of MicroCool Breathable Impervious Gown with Secure Fit Surgical, (Large and X-Large), Made in Honduras. The Kimberly Clark Micro COOL Surgical Gowns are sterile... on 2009-09-17. FDA classified it as Class II and gives the reason as "Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2018-2012
Classification: Class II
Status: Terminated
Initiated: 2009-09-17
Posted: 2012-07-16
Terminated: 2012-07-19
Recalling firm: Kimberly-Clark Corporation
Product: 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.
Product code: FYA Gown, Surgical
Reason for recall: Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Kimberly Clark sent an Urgent Medical Device Recall letter dated September 17, 2009. to all affected consignees. The Recall notification of the expanded recall was sent to consignees on November 17, 2009. Customers were instructed to destroy all affected product remaining in their inventory. For questions regarding this recall call 770-587-7400.
Distribution: Nationwide Distribution including AL, FL, GA, KY, LA, MS, NC, OH, SC, TN, and VA
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2018-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2017-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-25	2012-07-16
Z-2018-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-25	2012-07-16

Product code FYA

K091357Class IIMicrocool Surgical Gown, Breathable High Performance Kc400Kimberly-Clark Corp. / cleared 2009-08-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)