BD Recalls Catheters

Becton Dickinson and Co. (Franklin Lakes, NJ) said Wednesday it was voluntarily recalling certain manufacturing lots of its Insyte AutoGuard shielded IV catheter because of reports of localized skin irritation. Less than 0.01% of these products used have encountered the problem.

The company said there have been no confirmed reports of serious problems or complications. No reports indicate that this irritation contributes to any serious adverse health consequences.

The problem seems to stem from a modified formulation of the lubricant applied to certain needle gauges of the catheters. BD has discontinued use of the modified lubricant and has resumed use of its previous lubrication, which has been used since the product was introduced five years ago.

The recall does not affect other products. The company has offered to supply customers with alternate product during the period when the Insyte AutoGuard will not be available. BD estimates that the most popular sizes and types of the product will be available regionally beginning in mid-March, with near 100% availability nationally expected by mid-April.

The company acknowledged that the recall may "modestly" reduce revenue expectations for the fiscal quarter ending March 31.