Z-1664-2014Class II

Visitec Anterior Chamber Cannula, .40x22mm (27Gx7/8in) REF 585006 Cannulae are intended to irrigate and or...

Name: Z-1664-2014 Visitec Anterior Chamber Cannula, .40x22mm (27Gx7/8in) REF 585006 Cannulae are intended to irrigate and or...
Creator: Beaver-Visitec International Inc.
Published: 2014-05-06
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2014-05-06 / Terminated / root cause: packaging

FDA source

Beaver-Visitec International Inc. began a recall of Visitec Anterior Chamber Cannula, .40x22mm (27Gx7/8in) REF 585006 Cannulae are intended to irrigate and or aspirate ophthalmic solutions and liquids in or out... on 2014-05-06. FDA classified it as Class II and gives the reason as "Contains a sharp tip needle when the product should contain a blunt tip cannula". 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-1664-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-06
Posted: 2014-05-27
Terminated: 2014-09-05
Recalling firm: Becton Dickinson & Co
Product: Visitec Anterior Chamber Cannula, .40x22mm (27Gx7/8in) REF 585006 Cannulae are intended to irrigate and or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate. These products are used in all sections of the eye. This cannula is a general use cannula mainly designed for the precise maintenance of optimum anterior chamber depth
Product code: HMX Cannula, Ophthalmic
Reason for recall: Contains a sharp tip needle when the product should contain a blunt tip cannula
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Beaver Visitec (BVI) sent a Product Recall Notice dated May 6, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately return any un-opened product of the affected lot so that BVI can replace the product or issue credit to their company. Customers were asked to fax or email the customer response form to 866-906-4304 or [email protected] as acknowledgement of the letter. Customers with questions should call 781-906-7986. For questions regarding this recall call 781-906-7950.
Quantity in commerce: 9970 units
Distribution: Nationwide Distribution including AL, CT, IN, NC, NY, TX, and VA.
Product codes and lots: Lot number: 3079324

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1664-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1664-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-04	2014-05-27

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)