Z-0401-06

Milex 60cc Handy-Vak Locking Syringe Ref: MX500

Name: Z-0401-06 Milex 60cc Handy-Vak Locking Syringe Ref: MX500
Creator: CooperSurgical, Inc.
Published: 2005-11-01
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2005-11-01 / Terminated

FDA source

CooperSurgical, Inc. began a recall of Milex 60cc Handy-Vak Locking Syringe Ref: MX500 on 2005-11-01. The reason FDA records is "Potential for the plunger to separate from the piston". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0401-06
Status: Terminated
Initiated: 2005-11-01
Posted: 2006-01-18
Terminated: 2012-05-14
Recalling firm: CooperSurgical, Inc.
Product: Milex 60cc Handy-Vak Locking Syringe Ref: MX500
Product code: FMF Syringe, Piston
Reason for recall: Potential for the plunger to separate from the piston
FDA root cause: Other
Action: CooperSurgical notified consignees by telephone and follow-up letter dated 11/3/05 via fax. Accounts are requested to discontinue use and return inventory.
Quantity in commerce: 496 units
Distribution: CA, CO, HI, IL, MA, NH, PA, VA, WA Foreign: Canada
Product codes and lots: Lot number: 39608 Exp. Date April 08

Product code FMF

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)