Z-0644-03

Sterile 8 Fr Suction Catheter Kit - Latex Free; Medline Industries, Inc., Mundelein, IL 60060-4488; 50 kits...

Name: Z-0644-03 Sterile 8 Fr Suction Catheter Kit - Latex Free; Medline Industries, Inc., Mundelein, IL 60060-4488; 50 kits...
Creator: Medline Industries Inc
Published: 2003-02-12
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2003-02-12 / Terminated / root cause: labeling and UDI

FDA source

Medline Industries Inc began a recall of Sterile 8 Fr Suction Catheter Kit - Latex Free; Medline Industries, Inc., Mundelein, IL 60060-4488; 50 kits per case on 2003-02-12. The reason FDA records is "Some of the kits labeled as latex free contain latex gloves which are properly labeled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0644-03
Status: Terminated
Initiated: 2003-02-12
Posted: 2003-03-12
Terminated: 2003-08-12
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Sterile 8 Fr Suction Catheter Kit - Latex Free; Medline Industries, Inc., Mundelein, IL 60060-4488; 50 kits per case
Product code: GBX Catheter, Irrigation
Reason for recall: Some of the kits labeled as latex free contain latex gloves which are properly labeled.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Recalled by letter dated 2/11/03. The accounts were informed that some of the suction catheter trays labeled as latex free actually contained latex gloves. The latex glove wrapper has a latex warning on it. The accounts were instructed to return any of the suspect lot of trays to Medline for replacement or credit. The recall was expanded by letterdated 3/3/03 to include the one lot of dressing change trays for the same problem and the same instructions.
Quantity in commerce: 753 cases
Distribution: Nationwide and Canada
Product codes and lots: reorder #DYND40978, lot 02IA0387

Product code GBX

K822510Class ISuction Catheter W/sterile WaterMedine Dynacor / cleared 1982-10-13

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)