Oscor Inc. Issues Recall Product Expansion of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models)

Budget101 Discussion List Archives Recalls Oscor Inc. Issues Recall Product Expansion of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models)

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      budget

      On September 26, 2018 Oscor notified customers of a recall for certain lots (Recall No. 1035166- 09/07/2018-01-R) of TB Unshrouded Bipolar Pacing Leads. As part of the recall correction activities, Oscor is retrieving any remaining inventory out in the field.

      The recall scope is being expanded to include expired inventory for devices distributed between December 21, 2011 to May 17, 2018. The recall expansion is to ensure proper disposition of expired units. The FDA has been notified and is aware Oscor Inc.

      is voluntarily taking this action.

      Read More…

      This notice provided by Budget101.com

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Budget101 Discussion List Archives Recalls Oscor Inc. Issues Recall Product Expansion of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models)