Ultra Surgical Gown, Large with Polypropylene Fabric and Towel, Reference number 95111-35, Single use only, Sterile, Made in Honduras.
This recall has been terminated (originally issued January 18, 2011).
- Company
- Kimberly-Clark Corporation
- Recall Initiated
- December 23, 2010
- Posted
- January 18, 2011
- Terminated
- July 27, 2011
- Recall Number
- Z-0920-2011
- Quantity
- 200 cases (32 units per case)
- Firm Location
- Roswell, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Product was not properly sterilized.
Distribution
Nationwide Distribution -- CA, CT, LA, NJ, NM, RI, CO and TX.
Lot / Code Info
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.
Root Cause
Pending
Action Taken
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.