FDA Medical Device Recalls (openFDA)
Cypress Medical Products LLC: 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 number
- Z-2828-2018
- 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.
- Status
- Terminated
- Initiated
- 2018-07-02
- Posted
- not on file
- Terminated
- 2023-04-07
- 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.
- 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 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
- 66 cases
- Distribution
- US Nationwide Distribution in the states of in AL, AR, IA, LA, OK, TX, UT, and VA.
- Lot, serial or model codes
- CDZG09-30
- 510(k) numbers
- ["K093276"]
- PMA numbers
- not on file
- Product code
- LYZ
- Firm FEI
- 1451040
- Firm city
- Richmond
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28