Recall: Oscor Temporary Bipolar Pacing Lead, Model TB
On 2018-11-12, the FDA announced that Oscor is conducting a recall on Temporary Bipolar Pacing Lead, Model TB due to a possible undetermined hazard. The recalled products were sold under the brand name(s) Oscor during an unspecified time period throughout the regions shown in the map below.
In recent months, there have been 2 medical devices recalls due to potential undetermined hazard, including maquet/getinge cardiosave intra-aortic balloon pumps (iabp), extremity tourniquets and more. Additionally, there have been 2 drug and medical device recalls due to other health hazards as well as 81 food recalls.
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Detailed Recall Information
Regions Where Sold: Because the region was not specified, it is assumed that this product was available nationwide.
Product Description: Temporary Bipolar Pacing Lead, Model TB
Brand Name(s): Oscor
Reason for Recall: Undetermined Hazard
Official Recall Date: 2018-11-12
Additional information provided by the FDA.gov:
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.
More information may be available at FDA.gov
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Sources may include Food & Drug Administration (FDA), United States Department of Agriculture (USDA), Health Canada and companies involved with this or a related recall.