FDA Enforcement
Class II
Terminated
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.
Recall: Z-2828-2018
·
Reported August 22, 2018
Enforcement
- Recall Number
- Z-2828-2018
- Event ID
- 80669
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Cypress Medical Products LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 22, 2018
- Initiation Date
- July 2, 2018
- Classification Date
- August 16, 2018
- Termination Date
- April 7, 2023
- Address
- 9954 Mayland Dr, Richmond, VA, 23233-1464, United States
Description
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.
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.
Code Info
CDZG09-30
Distribution
US Nationwide Distribution in the states of in AL, AR, IA, LA, OK, TX, UT, and VA.
Quantity
66 cases