FDA Recall 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 · Initiated July 2, 2018

Recall

Recall Number
Z-2828-2018
Event Number
80669
Firm
Cypress Medical Products LLC
FEI Number
1451040
Product Code
LYZ
Status
Terminated
Root Cause
Nonconforming Material/Component
Initiated
July 2, 2018
Terminated
April 7, 2023
Address
9954 Mayland Dr, Richmond, VA, 23233-1464

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.

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 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 [email protected], 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, [email protected].

Distribution

US Nationwide Distribution in the states of in AL, AR, IA, LA, OK, TX, UT, and VA.

Quantity

66 cases