Z-1645-2009

Kimberly-Clark, Synthetic Powder Free Vinyl Exam Gloves, Small, Medium and Large, 100 gloves per box...

Name: Z-1645-2009 Kimberly-Clark, Synthetic Powder Free Vinyl Exam Gloves, Small, Medium and Large, 100 gloves per box...
Creator: Kimberly-Clark Corporation
Published: 2009-04-30
License: https://open.fda.gov/license/

Kimberly-Clark Corporation / initiated 2009-04-30 / Terminated

FDA source

Kimberly-Clark Corporation began a recall of Kimberly-Clark, Synthetic Powder Free Vinyl Exam Gloves, Small, Medium and Large, 100 gloves per box, Non-Sterile, For Medical Use, Catalogue Numbers: 55031... on 2009-04-30. The reason FDA records is "The product may contain defects/holes reducing the product's effectiveness as a barrier". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1645-2009
Status: Terminated
Initiated: 2009-04-30
Posted: 2009-05-26
Terminated: 2010-01-07
Recalling firm: Kimberly-Clark Corporation
Product: Kimberly-Clark, Synthetic Powder Free Vinyl Exam Gloves, Small, Medium and Large, 100 gloves per box, Non-Sterile, For Medical Use, Catalogue Numbers: 55031, 55032, and 55033. Distributed by Kimberly Clark LLC, Roswell, GA
Product code: LYZ Vinyl Patient Examination Glove
Reason for recall: The product may contain defects/holes reducing the product's effectiveness as a barrier.
FDA root cause: Release of Material/Component prior to receiving test results
Action: Consignees were contacted by an Urgent: Medical Recall letter on/about 4/30/2009. The letter instructs the Distributor to extend the recall to the end-user level by notifying each of their customers of the recall via a 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. Distributors were instructed to cease further shipment of the product and to physically quarantine the product and fax the completed Response Sheet within 5 business days of receipt of the letter. The customer was instructed to immediately cease further use of the gloves and physically quarantine the product and fax the completed Response Sheet within 5 business days of receipt of the letter. Upon receipt of the Response Sheets, KC will arrange pick-up of the affected products and deliver it to a quarantine location at the contracted warehouse.
Quantity in commerce: 920 cases/10 boxes per case
Distribution: Nationwide Distribution -- USA including states of CT, MA, MD, NJ, and NY.
Product codes and lots: Lot number SG8326661.

Product code LYZ

K992821Class ISynthetic Powder-Free Vinyl Patient Examination GlovesShijiazhuang Hongxiang Plastics Products Co., Ltd. / cleared 2000-03-10

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)