FDA Medical Device Recalls (openFDA)
Medline Industries Inc: Medline Blue O.R. Towel, Sterile; Reorder MDT2168204; 4 towels per pack, 20 packs per case; Medline Industries, Inc., Mundelein, IL 60060-4486
- Recall number
- Z-0114-04
- Recalling firm
- Medline Industries Inc
- Product
- Medline Blue O.R. Towel, Sterile; Reorder MDT2168204; 4 towels per pack, 20 packs per case; Medline Industries, Inc., Mundelein, IL 60060-4486
- Status
- Terminated
- Initiated
- 2003-10-07
- Posted
- 2003-11-13
- Terminated
- 2003-11-12
- Reason
- The product, labeled as sterile, had not gone through the sterilization process at the time of shipment.
- Root cause
- Other
- Action
- Medline telephoned their sales represntatives on 10/7/03, instructing them to visit their accounts who received lot 03IA0532 and retrieve all cases of the lot distributed due to a quality issue. The accounts were informed that replacement product would be provided for the returned product.
- Quantity
- 44 cases
- Distribution
- Ohio, Iowa, Illinois, Wisconsin and Indiana
- Lot, serial or model codes
- Reorder #MDT2168204, lot 03IA0532
- 510(k) numbers
- K962205
- PMA numbers
- not on file
- Product code
- KKX
- 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