Z-0920-2011

Ultra Surgical Gown, Large with Polypropylene Fabric and Towel, Reference number 95111-35, Single use only...

Name: Z-0920-2011 Ultra Surgical Gown, Large with Polypropylene Fabric and Towel, Reference number 95111-35, Single use only...
Creator: Kimberly-Clark Corporation
Published: 2010-12-23
License: https://open.fda.gov/license/

Kimberly-Clark Corporation / initiated 2010-12-23 / Terminated / root cause: sterility

FDA source

Kimberly-Clark Corporation began a recall of Ultra Surgical Gown, Large with Polypropylene Fabric and Towel, Reference number 95111-35, Single use only, Sterile, Made in Honduras on 2010-12-23. The reason FDA records is "Product was not properly sterilized". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0920-2011
Status: Terminated
Initiated: 2010-12-23
Posted: 2011-01-18
Terminated: 2011-07-27
Recalling firm: Kimberly-Clark Corporation
Product: Ultra Surgical Gown, Large with Polypropylene Fabric and Towel, Reference number 95111-35, Single use only, Sterile, Made in Honduras.
Product code: FYA Gown, Surgical
Reason for recall: Product was not properly sterilized.
Root cause tag: sterility
FDA root cause: Pending
Action: Kimberly-Clark contacted all ten (10) Distributors with a Distributor Recall Letter (sent FedEx Priority overnight) on 12/23/2010, as well as via telephone. This letter instructs the Distributor to extend the Recall to end-user level by notifying each of their customers of the Recall via the provided Customer Recall Letter. Both the Distributor Letter and Customer Letter include Response Sheets that allows for both Distributor and Customer (end-user) to indicate the quantity of affected product they have in their inventory or indicate whether they do not have any affected product. The Distributor is instructed to immediately cease further shipment of the product and to physically quarantine the product, and fax the completed Response Sheet to our firm's Recall Coordinator within 5 business days of receipt of the letter. The Customer is instructed to immediately cease further use of the gowns and physically quarantine the product, and fax the completed Customer Product Response Sheet to Kimberly Clark's Recall Coordinator within 5 business days of receipt of the letter. Upon receipt of the Response Sheets, the firm will provide instructions for the return of the impacted gowns for delivery to a quarantine location at our warehouse.
Quantity in commerce: 200 cases (32 units per case)
Distribution: Nationwide Distribution -- CA, CT, LA, NJ, NM, RI, CO and TX.
Product codes and lots: Product code (Large Surgical Gowns): 95111-35, Case Lot Numbers: AH0319YL0, AH0319YLI, AH0319YM4, AH0319YLH, AH0319YLJ, AH0319YM3, AH0320YMD, AH0320YME, AH0320YMF, AH0320YMG, AH0320YMN, AH0320YMM, AH0320YMH, AH0320YN0, AH0320YNC, AH0320YND, AH0320YNJ, AH0320YNI, AH0320YNK; Individual Unit Lot Numbers (printed on the sterile pouch): AH0319A, AH0319B, AH0319C, AH0320A, AH0320B, AH0320C.

Product code FYA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)