Beaver-Visitec International (Beaver-Visitec) BD 1% OVD Sodium Hyaluronate, 10 mg/ml 1.0 mL. Sterile. Rx For Intraocular

FDA device recall Z-0606-2011 · posted 2010-12-16 · Terminated

Recall details

Recalling firm

Becton Dickinson and Company

Reason for recall

Finger flange on the BD 1% OVD syringe can disengage during cataract surgery and and may lead to injury.

Action taken

Beaver Visitec issued an Urgent: Field Safety Notice letter, dated 10/4/10 to direct accounts, identifying the affected product and informing users of the potential for the finger grip to disengage during use. The firm offers solutions as follows: Allow the finger grip to remain attached to the syringe and continue to use the product. Position the open side of the finger grip towards the palm to avoid detachment of the grip from the syringe. Remove the finger grip and continue to use the product. Return the unused product to Beaver-Visitec for reimbursement. Users were requested to complete the Customer Response Form. Questions can be directed to: Inside Sales at 781-906-7952.

Root cause

Component design/selection

Status

Terminated

Product code

LZP

Quantity affected

72278 units

Distribution

Nationwide Distribution

Date initiated

2010-10-04

Date posted

2010-12-16

Date terminated

2012-02-16

Location

Waltham, MA