| Class 2 Device Recall McKesson Powder Free Vinyl Exam Gloves | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = LYZ
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