FDA Medical Device Recalls (openFDA)
Medline Industries, Inc.: Proxima Sterile, Disposable Set Up Pack III, Reorder DYNJP1047; a sterilized convenience kit for surgical procedures comprised of 2 Aurora Gowns, 1 Mayo stand cover, 10 O.R. towels and 1 table cover; 5 kits per case; Manufactured for Medline Inductries, Inc., Mundelien, IL 60060 U.S.A., Made in China
- Recall number
- Z-0777-06
- Recalling firm
- Medline Industries, Inc.
- Product
- Proxima Sterile, Disposable Set Up Pack III, Reorder DYNJP1047; a sterilized convenience kit for surgical procedures comprised of 2 Aurora Gowns, 1 Mayo stand cover, 10 O.R. towels and 1 table cover; 5 kits per case; Manufactured for Medline Inductries, Inc., Mundelien, IL 60060 U.S.A., Made in China
- Status
- Terminated
- Initiated
- 2006-03-30
- Posted
- 2006-04-19
- Terminated
- 2006-05-09
- Reason
- The product may not be sterile. The pouches were damaged during sterilization.
- Root cause
- Other
- Action
- The direct account hospital was visited by a Medline sales representative on 3/30/06, and the affected product was retrieved and returned to Medline.
- Quantity
- 21 cases
- Distribution
- Texas
- Lot, serial or model codes
- Reorder number DYNJP1047, lot 5149116
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 3000717925
- Firm city
- Waukegan
- 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