Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall McKesson Powder Free Vinyl Exam Gloves

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall McKesson Powder Free Vinyl Exam Gloves see related information
Date Initiated by Firm July 02, 2018
Create Date August 16, 2018
Recall Status1 Terminated 3 on April 07, 2023
Recall Number Z-2828-2018
Recall Event ID 80669
510(K)Number K093276  
Product Classification Vinyl patient examination glove - Product Code LYZ
Product 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.
Code Information CDZG09-30
Recalling Firm/
Manufacturer		 Cypress Medical Products LLC
9954 Mayland Dr
Richmond VA 23233-1464
For Additional Information Contact Ms. Jill Early
805-553-2146
Manufacturer 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
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 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.
Quantity in Commerce 66 cases
Distribution US Nationwide Distribution in the states of in AL, AR, IA, LA, OK, TX, UT, and VA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LYZ and Original Applicant = TANGSHAN KANGYUAN GLOVE CO., LTD.
-
-