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.
FDA Recall Z-2828-2018 · Posted None
Advertisement
Recalling FirmCypress Medical Products LLC
Recall StatusTerminated
Product CodeLYZ
Date Initiated2018-07-02
Date Terminated2023-04-07
Product Quantity66 cases
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.
Firm 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].
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide Distribution in the states of in AL, AR, IA, LA, OK, TX, UT, and VA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement