FDA Medical Device Recalls (openFDA)
Kimberly-Clark Corporation: Ultra Surgical Gown, X-Large with Polypropylene Fabric and Towel, Reference number 95121-35, Single use only, Sterile, Made in Honduras.
- Recall number
- Z-0921-2011
- Recalling firm
- Kimberly-Clark Corporation
- Product
- Ultra Surgical Gown, X-Large with Polypropylene Fabric and Towel, Reference number 95121-35, Single use only, Sterile, Made in Honduras.
- Status
- Terminated
- Initiated
- 2010-12-23
- Posted
- 2011-01-18
- Terminated
- 2011-07-27
- Reason
- Product was not properly sterilized.
- 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
- 40 cases (32 units per case)
- Distribution
- Nationwide Distribution -- CA, CT, LA, NJ, NM, RI, CO and TX.
- Lot, serial or model codes
- Product code (Extra Large Surgical Gowns): 95121-35, Case Lot Numbers: AH0319YL3, AH0320YNF, AH0320YNB, AH0320YNA, AH0320YNG; Individual Unit Lot Numbers (printed on the sterile pouch): AH0319A, AH0319B, AH0319C, AH0320A, AH0320B, AH0320C.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FYA
- Firm FEI
- 1000015879
- Firm city
- Roswell
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28