Z-1066-2019Class II

BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in). The BVI Soft Tip Cannula is intended to...

Name: Z-1066-2019 BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in). The BVI Soft Tip Cannula is intended to...
Creator: Beaver Visitec
Published: 2018-11-30
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2018-11-30 / Terminated / root cause: manufacturing process

FDA source

Beaver Visitec began a recall of BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in). The BVI Soft Tip Cannula is intended to irrigate and/or aspirate ophthalmic solutions and... on 2018-11-30. FDA classified it as Class II and gives the reason as "Certain lots are missing a protective sheath component over the silicone tip, which may result in the silicone tip breaking or detaching at the metal tube component. If the tip becomes detached during a procedure while...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1066-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-30
Posted: 2019-03-27
Terminated: 2020-05-01
Recalling firm: Becton Dickinson & Co
Product: BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in). The BVI Soft Tip Cannula is intended to irrigate and/or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate (e.g. retinal, subretinal procedures).
Product code: HMX Cannula, Ophthalmic
Reason for recall: Certain lots are missing a protective sheath component over the silicone tip, which may result in the silicone tip breaking or detaching at the metal tube component. If the tip becomes detached during a procedure while in the eye, the fragment will need to be retrieved to mitigate the possibility of injury.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 11/30/18, the firm sent an "Urgent: Medical Device Recall" letter dated 11/30/2018 to its customers advising them of the product issue. The letter described the product, problem and actions to be taken. Customers were advised to take the following actions: 1. Immediately examine your inventory and quarantine product from the lots subject to recall. If you may have further distributed this product, please identify your customers and notify them at once of this product recall. Consider all potential users of this product in your user supply chain. You may be supported by including a copy of this recall notification letter. Your assistance is appreciated and necessary to prevent patient harm. 2. Complete and return the enclosed Product Recall Notice Response & Return Form IMMEDIATELY as evidence of the product being returned and we will credit your account OR complete the response form even if you do not have product to return and Fax 866-906-4304 or email a copy to [email protected]. Please include a copy of the completed Response & Return Form with your shipment in Step 3 below. 3. Return ALL quarantined product from the affected lots to our company utilizing the Return Merchandise label that is included with this letter. You may use the prepaid BVI FedEx number for your return. If you have any specific product replacement questions you may contact the Customer Service Team at: [email protected] or call 866-906-8080 from 8:00am to 6:00pm EST (Monday Through Friday). If you have any further questions, contact the Manager, Regulatory Affairs at Phone: 866-906-8080 or 781-906-6925.
Quantity in commerce: 3430 units
Distribution: Worldwide distribution: US (nationwide) to states of: AR, AZ, CA, CO, FL, GA, LA, MD, MO, NC, NE, NJ, NY, OH, OK, TX, UT, VA, WA; and countries of: Mexico and Peru.
Product codes and lots: Lots 60047S4, 60060S9, 600623S

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1066-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1066-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-03	2019-03-27

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