Recall Z-0741-2017 ยท LYZ Vinyl Patient Examination Glove
CYPRESS MEDICAL PRODUCTS
McKesson Powder Free Vinyl Exam Gloves Catalog numbers 14-116, 14-118, 14-120, 14-136, 14-138 and 14-140
| Date | Dec 12, 2016 (initiated Oct 12, 2016) |
| Status | Terminated |
| Reason | A container of McKesson vinyl gloves that failed the FDA leak test was inadvertently distributed. |
| Root cause | Process control |
| Action | A letter, dated October 19, 2016, on Cypress Medical Products letterhead, was sent to customers. Customers were requested to stop use and quarantine the gloves. |
| Quantity | 2005.2 cases have been distributed |
| Distribution | US Distribution. This recall is limited to one distribution center in Auburn, Washington, and the customers serviced from that distribution center. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120968 | POWER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) Tangshan Zhonghong Pulin Plastic Co.,Ltd, Sep 19, 2012 |