Recall Z-2828-2018 ยท LYZ Vinyl Patient Examination Glove
Cypress Medical Products LLC
Powder Free Vinyl Exam Gloves, Item Nos. 14-116, 14-118 Product Usage: Medical exam glove for use by professional healthcare workers and/or consumers.
| Date | Jul 2, 2018 |
| Status | Terminated |
| Reason | The firm is recalling one lot of McKesson Powder Free Vinyl Exam Gloves because a sample of product from that lot did not meet certain release specifications. It is possible that certain gloves from this lot may not be of medical exam quality and, therefore, may not provide an effective barrier to infectious material. |
| Root cause | Nonconforming Material/Component |
| Action | On July 2, 2018, Cypress Medical Products LLC notified its customer, McKesson Medical-Surgical, that it was planning to recall distributed products. McKesson Medical-Surgical then notified the affected distribution center as well as end users. End users were sent an Urgent Voluntary Medical Device Recall letter. The letter informed users that the firm is voluntarily recalling one lot of gloves because a sample of product from that lot did not meet certain release specifications. Customers were instructed to do the following: 1. Check stock for affected product. 2. Immediately cease distri |
| Quantity | 66 cases |
| Distribution | US Nationwide Distribution in the states of in AL, AR, IA, LA, OK, TX, UT, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093276 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Tangshan Kangyuan Glove Co., Ltd., Nov 4, 2009 |