Ultra Surgical Gown, X-Large with Polypropylene Fabric and Towel, Reference number 95121-35, Single use only, Sterile, M

FDA device recall Z-0921-2011 · posted 2011-01-18 · Terminated

Recall details

Recalling firm

Kimberly-Clark Corporation

Reason for recall

Product was not properly sterilized.

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.

Root cause

Pending

Status

Terminated

Product code

FYA

Quantity affected

40 cases (32 units per case)

Distribution

Nationwide Distribution -- CA, CT, LA, NJ, NM, RI, CO and TX.

Date initiated

2010-12-23

Date posted

2011-01-18

Date terminated

2011-07-27

Location

Roswell, GA