Z-1092-04

Introcan Safety IV Catheter 22G x 1'' PUR with Wings. The affected catalogs and lot numbers: Catalog Number...

Name: Z-1092-04 Introcan Safety IV Catheter 22G x 1'' PUR with Wings. The affected catalogs and lot numbers: Catalog Number...
Creator: Braun,B Medical Inc
Published: 2004-03-19
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2004-03-19 / Terminated / root cause: labeling and UDI

FDA source

Braun,B Medical Inc began a recall of Introcan Safety IV Catheter 22G x 1'' PUR with Wings. The affected catalogs and lot numbers: Catalog Number 4253540 - Lot number 3G26258U02 Catalog Number... on 2004-03-19. The reason FDA records is "Mislabeled product. The recalling firm received a complaint that a box of Introcan Safety Catheters, (22G x 1 inch) contained mixed 18G catheters with the same lot number". 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-1092-04
Status: Terminated
Initiated: 2004-03-19
Posted: 2004-07-20
Terminated: 2004-09-21
Recalling firm: B Braun Medical Inc
Product: Introcan Safety IV Catheter 22G x 1'' PUR with Wings. The affected catalogs and lot numbers: Catalog Number 4253540 - Lot number 3G26258U02 Catalog Number 4253540 - Lot number 3G27258U02
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: Mislabeled product. The recalling firm received a complaint that a box of Introcan Safety Catheters, (22G x 1 inch) contained mixed 18G catheters with the same lot number.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The recalling firm received a product complaint of a mixed 18G Catheters with 22G Catheters.
Quantity in commerce: 86 units
Distribution: The affected recalling units were distributed nationwide to the following states: AZ, CA, GA, IL, IN, MD, OH, OK, OR, MA, MI, NC, NJ, NY, OR, PA, TX, UT, VA, WI
Product codes and lots: Catalog Number is 4253540 and the lot numbers are 3G26258U02 and 3G27258U02

Product code FOZ

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)