Draft Guidance of Lists of Retail Consignees Issued by FDA for Food Recalls

TB — Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models) Recalled

Not sure what’s been recalled, withdrawn from the market, or had safety updates? Catch up on the US Food and Drug Administration’s (FDA’s) recalls and market withdrawals from this past week. Oscor Inc. is issuing a recall of TB - Temporary Bipolar Pacing Leads featuring the 2mm unshrouded connectors due to possible malfunction with the connector cap housing (see Picture 1, No. 2 Pin Cap and Cover), which may interrupt the pacing system.

A design change of the cap housing of the pins was attributed for the device failures from analyses of the returned devices, which may cause the connectors to separate during use.

Four serious injuries attributed a connector cap malfunction were reported in the last 6 years. While no deaths have been reported, the risk for possible injury is a concern

Draft Guidance of Lists of Retail Consignees Issued by FDA for Food Recalls

For more information on this recall, check out the FDA’s statement. The FDA has announced the availability of draft guidance entitled “Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls” for industry and FDA staff regarding food recalls.

The new document will provide guidance on how and when the FDA intends to collect, compile, and publicize retail consignees that may have received recalled foods.

The guidance will also allow the FDA to publicize retail consignee lists for other food recalls provided the food will cause serious adverse health consequences or death to humans or animals (Class I recalls).

With the guidance, the FDA will aim to publicize retail consignee lists for these food recalls to help consumers quickly and effectively identify recalled food and determine whether that food is in their possession.

For more information on this draft guidance, check out the FDA’s statement.