Z-0444-03

UltraSafe Dental Needle Guard, P/N: 401801 Lot:T20201501

Name: Z-0444-03 UltraSafe Dental Needle Guard, P/N: 401801 Lot:T20201501
Creator: Safety Syringes Inc
Published: 2002-09-05
License: https://open.fda.gov/license/

Safety Syringes, Inc. / initiated 2002-09-05 / Terminated / root cause: packaging

FDA source

Safety Syringes Inc began a recall of UltraSafe Dental Needle Guard, P/N: 401801 Lot:T20201501 on 2002-09-05. The reason FDA records is "Package integrity not validated. Sterility not assured". 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-0444-03
Status: Terminated
Initiated: 2002-09-05
Posted: 2003-01-14
Terminated: 2003-12-03
Recalling firm: Safety Syringes, Inc.
Product: UltraSafe Dental Needle Guard, P/N: 401801 Lot:T20201501
Product code: MEG Syringe, Antistick
Reason for recall: Package integrity not validated. Sterility not assured.
Root cause tag: packaging
FDA root cause: Other
Action: Firm initiated recall on 9/5/2002. Visits, telephone calls and letters were the tools used to implement the recall. Unused recalled units were retrieved from customers. This recall is complete.
Quantity in commerce: 3300
Distribution: Medical offices located in California.
Product codes and lots: Lot T20201501

Product code MEG

K013801Class IIUltrasafe Dental Injection SystemSafety Syringes, Inc. / cleared 2001-12-13

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)