Z-0777-06

Proxima Sterile, Disposable Set Up Pack III, Reorder DYNJP1047; a sterilized convenience kit for surgical...

Name: Z-0777-06 Proxima Sterile, Disposable Set Up Pack III, Reorder DYNJP1047; a sterilized convenience kit for surgical...
Creator: Medline Industries, Inc.
Published: 2006-03-30
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2006-03-30 / Terminated / root cause: packaging

FDA source

Medline Industries, Inc. began a recall of Proxima Sterile, Disposable Set Up Pack III, Reorder DYNJP1047; a sterilized convenience kit for surgical procedures comprised of 2 Aurora Gowns, 1 Mayo stand... on 2006-03-30. The reason FDA records is "The product may not be sterile. The pouches were damaged during sterilization". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0777-06
Status: Terminated
Initiated: 2006-03-30
Posted: 2006-04-19
Terminated: 2006-05-09
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
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
Product code: LRO General Surgery Tray
Reason for recall: The product may not be sterile. The pouches were damaged during sterilization.
Root cause tag: packaging
FDA 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 in commerce: 21 cases
Distribution: Texas
Product codes and lots: Reorder number DYNJP1047, lot 5149116

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)