Z-2163-2011

S5-7604 Silicone Oil Injection Cannula 4mm Long - 20G REF 585246 High Viscosity Injectors are used during...

Name: Z-2163-2011 S5-7604 Silicone Oil Injection Cannula 4mm Long - 20G REF 585246 High Viscosity Injectors are used during...
Creator: Becton Dickinson and Company
Published: 2010-12-17
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2010-12-17 / Terminated

FDA source

Becton Dickinson and Company began a recall of S5-7604 Silicone Oil Injection Cannula 4mm Long - 20G REF 585246 High Viscosity Injectors are used during retinal surgery for fluid infusion. A High Viscosity... on 2010-12-17. The reason FDA records is "Restricted or no fluid flow for Visitec High Viscosity Injector". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2163-2011
Status: Terminated
Initiated: 2010-12-17
Posted: 2011-05-10
Terminated: 2013-07-03
Recalling firm: Becton Dickinson & Co
Product: S5-7604 Silicone Oil Injection Cannula 4mm Long - 20G REF 585246 High Viscosity Injectors are used during retinal surgery for fluid infusion. A High Viscosity Injector is placed into the sclera and temporarily sutured into place
Product code: HMX Cannula, Ophthalmic
Reason for recall: Restricted or no fluid flow for Visitec High Viscosity Injector.
FDA root cause: Component change control
Action: Beaver Visitec (BVI) notified customers via telephone and by sending an Urgent Recall Customer Notification letter dated December 7, 2010. The letter identified the product, the problem, and the action to be taken by the customer. , Customers were requested to return all unused product in their inventory for credit or refund and complete the attached Customer Response Form and return it by fax to 781-893-7957. Questions can be directed to Inside Sales Manager at 781-906-7952.
Quantity in commerce: 1500 units
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Israel, Jordan, Russia, Saudi Arabia, South Africa, Turkey, Iraq, Lebanon, Morocco, Tunisia, Syria, India, Argentina, Australia, Austria, New Zealand, China, UK, Germany, Russia, Belgium, Italy, France, Sweden, and Ireland.
Product codes and lots: Lot #: 0106446 Exp Date: 2015-04 Lot #: 0152228, Exp Date: 2015-06

Product code HMX

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)