Recall Z-1645-2009 ยท LYZ Vinyl Patient Examination Glove
Kimberly-Clark Corporation
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
| Date | May 26, 2009 (initiated Apr 30, 2009) |
| Status | Terminated |
| Reason | The product may contain defects/holes reducing the product's effectiveness as a barrier. |
| 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 quarant |
| Quantity | 920 cases/10 boxes per case |
| Distribution | Nationwide Distribution -- USA including states of CT, MA, MD, NJ, and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992821 | SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Shijiazhuang Hongxiang Plastics Products Co., Ltd., Mar 10, 2000 |