FDA Medical Device Recalls (openFDA)
Medline Industries Inc: Medline Industries, Inc. "Cedar" brand Vinyl Economy Exam Glove, Powder-Free, Large Size, Catalog Number: MSV403P, Lot Number: JCU04958569
- Recall number
- Z-1554-2011
- Recalling firm
- Medline Industries Inc
- Product
- Medline Industries, Inc. "Cedar" brand Vinyl Economy Exam Glove, Powder-Free, Large Size, Catalog Number: MSV403P, Lot Number: JCU04958569
- Status
- Terminated
- Initiated
- 2011-02-03
- Posted
- 2011-03-04
- Terminated
- 2012-03-19
- Reason
- The recall was initiated because the affected lot, lot number JCU004958569, of gloves did not meet the requirements for the water-leak test.
- Root cause
- Release of Material/Component prior to receiving test results
- Action
- MEDLINE INDUSTRIES, INC. sent a RECALL NOTICE IMMEDIATE ACTION REQUIRED letter by US Mail on February 10, 2011, to all affected cusomters. The letter identified the product, the problem, and the action to be taken by the customer. The customers were instructed to: 1. Immediately quarantine ALL inventory of the affected lot for return to Medline. 2. Complete the attached recall verification form. Please complete this form EVEN IF you have none of the affected lot in stock. 3. Fax or email the completed form to Medline. The email address is Recalls@Medline.com or faxed the form to 866-767-1290. Customers with questions regarding the recall were instructed to contact Medline at 1-866-359-1704 or via e-mail at Recalls@Medline.com.
- Quantity
- 696 cases (696,000 units)
- Distribution
- Nationwide Distribution including CA, HI, and NV.
- Lot, serial or model codes
- Lot Number: JCU04958569
- 510(k) numbers
- ["K081655"]
- PMA numbers
- not on file
- Product code
- OIG
- Firm FEI
- 1417592
- Firm city
- Mundelein
- Firm state
- IL
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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