Z-0226-05

Portex Hypodermic Needle-Pro 5 ml Syringe, 22g x 1 '' Needle Catalog Number: 4254

Name: Z-0226-05 Portex Hypodermic Needle-Pro 5 ml Syringe, 22g x 1 '' Needle Catalog Number: 4254
Creator: Smiths Medical ASD, Inc.
Published: 2004-09-09
License: https://open.fda.gov/license/

Abbott Medical / initiated 2004-09-09 / Terminated / root cause: packaging

FDA source

Smiths Medical ASD, Inc. began a recall of Portex Hypodermic Needle-Pro 5 ml Syringe, 22g x 1 '' Needle Catalog Number: 4254 on 2004-09-09. The reason FDA records is "Sterility of the device is compromised due to packaging defects". 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-0226-05
Status: Terminated
Initiated: 2004-09-09
Posted: 2004-11-24
Terminated: 2012-05-08
Recalling firm: Abbott Medical
Product: Portex Hypodermic Needle-Pro 5 ml Syringe, 22g x 1 '' Needle Catalog Number: 4254
Product code: FMJ Manometer, Spinal-Fluid
Reason for recall: Sterility of the device is compromised due to packaging defects
Root cause tag: packaging
FDA root cause: Other
Action: Smiths Medical, ASD notified consignees by letter dated September 9, 2004 by FedEx. Customers and dealers are directed to fax back the attached Reply Letter to the Smiths Medical Regulatory Affairs Department at 603-358-1017, even if the customer/dealer no longer has affected products in inventory, Questions are directed to Customer Service at 1-800-258-5361, prompt 1. On 9/17/04, Smiths notified 48 consignees by Fed''X letter of 3 -additional lot codes for Product Code: 4252.
Distribution: Nationwide
Product codes and lots: Lot numbers starting with: 1, K1, K2, K50, K51, K52, K53

Product code FMJ

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)