Z-0858-05

Portex Hypodermic Needle-Pro Syringe & Needle 3mL/LL 25G x1'' Catalog Number: 4238

Name: Z-0858-05 Portex Hypodermic Needle-Pro Syringe & Needle 3mL/LL 25G x1'' Catalog Number: 4238
Creator: Smiths Medical ASD, Inc.
Published: 2005-05-05
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-05-05 / Terminated / root cause: labeling and UDI

FDA source

Smiths Medical ASD, Inc. began a recall of Portex Hypodermic Needle-Pro Syringe & Needle 3mL/LL 25G x1'' Catalog Number: 4238 on 2005-05-05. The reason FDA records is "Mislabeled: Product may contain an incorrect needle size. Product labeled as a 25G x 1" may contain a 25G x 5/8"". 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-0858-05
Status: Terminated
Initiated: 2005-05-05
Posted: 2005-06-01
Terminated: 2012-05-08
Recalling firm: Abbott Medical
Product: Portex Hypodermic Needle-Pro Syringe & Needle 3mL/LL 25G x1'' Catalog Number: 4238
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: Mislabeled: Product may contain an incorrect needle size. Product labeled as a 25G x 1" may contain a 25G x 5/8"
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Smith Medical notified dealers of the recall on May 5, 2005 by telephone. The remaining customers were notified on May 12, 2005 by telephone. Follow-up letter delivered by Federal Express on May 17, 2005.
Quantity in commerce: 159 cases (400 per case) =63,600 each.
Distribution: Nationwide
Product codes and lots: Lot Number: K621494

Product code FMI

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)