Food, drugs, devices › Beaver-Visitec International Inc.
Device recall: Visitec Anterior Chamber Cannula, .40x22mm (27Gx7/8in) REF 585006 Cannulae are intended to irrigate and or aspirate opht
Beaver-Visitec International Inc. (Waltham, MA) initiated this device recall on 6 May 2014; FDA lists 1 product record under event 68281, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 5 Sep 2014. Initiation: voluntary: firm initiated. Beaver-Visitec International Inc. has 18 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Beaver-Visitec International Inc., Waltham, MA.
Reason for recall
"Contains a sharp tip needle when the product should contain a blunt tip cannula"
Distribution
"Nationwide Distribution including AL, CT, IN, NC, NY, TX, and VA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1664-2014 | 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… | 9970 units | Class II | Terminated | 4 Jun 2014 |
Context
Other enforcement events for Beaver-Visitec International Inc.
All 18 events for Beaver-Visitec International Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Contains a sharp tip needle when the product should contain a blunt tip cannula"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide Distribution including AL, CT, IN, NC, NY, TX, and VA."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 5 Sep 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.