Z-2828-2018Class II

Powder Free Vinyl Exam Gloves, Item Nos. 14-116, 14-118

Name: Z-2828-2018 Powder Free Vinyl Exam Gloves, Item Nos. 14-116, 14-118
Creator: Cypress Medical Products LLC
Published: 2018-07-02
License: https://open.fda.gov/license/

Cypress Medical Products LLC / initiated 2018-07-02 / Terminated / root cause: manufacturing process

FDA source

Cypress Medical Products LLC began a recall of 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 on 2018-07-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2828-2018
Classification: Class II
Status: Terminated
Initiated: 2018-07-02
Posted: 2018-08-16
Terminated: 2023-04-07
Recalling firm: Cypress Medical Products LLC
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.
Product code: LYZ Vinyl Patient Examination Glove
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.
Root cause tag: manufacturing process
FDA root cause: 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 [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].
Quantity in commerce: 66 cases
Distribution: US Nationwide Distribution in the states of in AL, AR, IA, LA, OK, TX, UT, and VA.
Product codes and lots: CDZG09-30

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2828-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2828-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-16

Product code LYZ

K093276Class IPowder-Free Vinyl Patient Examination GlovesTangshan Kangyuan Glove Co., Ltd. / cleared 2009-11-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)