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.
This recall has been terminated (originally issued July 2, 2018).
- Company
- Cypress Medical Products Llc
- Recall Initiated
- July 2, 2018
- Terminated
- April 7, 2023
- Recall Number
- Z-2828-2018
- Quantity
- 66 cases
- Firm Location
- Richmond, VA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Nationwide Distribution in the states of in AL, AR, IA, LA, OK, TX, UT, and VA.
Lot / Code Info
CDZG09-30
Root Cause
Nonconforming Material/Component
Action Taken
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 distribution or use of the affected product, and quarantine immediately. 3. Complete the reply form included with the letter and return to Rachel Weaver at Rachel.Weaver@McKesson.com, even if you do not have any affected product in your possession. 4. If you have further distributed this product, please notify your customers who received this product about this recall and inform them how to return affected product. Affected product on hand at customer sites should be returned to the distribution center. Counts of returned, quarantined quantities should be forwarded to Cypress for tracking. If you have questions concerning the recall, please contact Ms. Jill Early: 804-553-2146, Jill.Early@McKesson.com.