Z-1078-04

Portex Hypodermic Needle-Pro Syringe and Needle 1ml/LS Small Gauge Safety 27 g x 1/2'' Reference Number: 4313

Name: Z-1078-04 Portex Hypodermic Needle-Pro Syringe and Needle 1ml/LS Small Gauge Safety 27 g x 1/2'' Reference Number: 4313
Creator: Smiths Medical ASD, Inc.
Published: 2004-06-29
License: https://open.fda.gov/license/

Abbott Medical / initiated 2004-06-29 / Terminated / root cause: sterility

FDA source

Smiths Medical ASD, Inc. began a recall of Portex Hypodermic Needle-Pro Syringe and Needle 1ml/LS Small Gauge Safety 27 g x 1/2'' Reference Number: 4313 on 2004-06-29. The reason FDA records is "Sterility of product is not assured". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1078-04
Status: Terminated
Initiated: 2004-06-29
Posted: 2004-07-20
Terminated: 2006-05-02
Recalling firm: Abbott Medical
Product: Portex Hypodermic Needle-Pro Syringe and Needle 1ml/LS Small Gauge Safety 27 g x 1/2'' Reference Number: 4313
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: Sterility of product is not assured
Root cause tag: sterility
FDA root cause: Other
Action: Smiths Medical notified consignees by telephone on June 29, 2004. The consignees were asked to immediately quarantine their stock . The Dealers and direct customers were contacted via letter delivered by Federal Express on July 2, 2004.
Quantity in commerce: 180 CASES (400/CS)
Distribution: Nationwide
Product codes and lots: Lot Number: K527299

Product code FMI

K011925Class IIHypodermic Needle-Pro Needle with Needle Protection Device; Hypodermic Needle-Pro Syringe & Needle with Needle ProtectioSims Portex, Inc. / cleared 2001-07-12

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)