Recall Z-0741-2017— CYPRESS MEDICAL PRODUCTS

Name: FDA recall Z-0741-2017
Creator: U.S. Food and Drug Administration
Published: 2016-10-12

Class II · Terminated

Class II FDA medical device recall by CYPRESS MEDICAL PRODUCTS, initiated 2016-10-12, terminated 2017-03-27. It names one FDA 510(k) clearance: K120968. Product: McKesson Powder Free Vinyl Exam Gloves Catalog numbers 14-116, 14-118, 14-120, 14-136, 14-138 and 14-140. Reason: A container of McKesson vinyl gloves that failed the FDA leak test was inadvertently distributed..

Recalling firm: CYPRESS MEDICAL PRODUCTS
Classification: Class II
Status: Terminated
Initiated: 2016-10-12
Terminated: 2017-03-27
Firm location: Richmond, VA, United States

510(k) clearances named in this recall

1 on FDA's record

K120968 — POWER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)Tangshan Zhonghong Pulin Plastic Co.,Ltd·cleared 2012-09-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

McKesson Powder Free Vinyl Exam Gloves Catalog numbers 14-116, 14-118, 14-120, 14-136, 14-138 and 14-140

Reason for recall

A container of McKesson vinyl gloves that failed the FDA leak test was inadvertently distributed.

Data sourced from openFDA. This site is unofficial and independent of the FDA.