BD is recalling the product because if a third-party screw is used, or potentially if the BD manufactured pivot latch screw is reused or improperly installed, it may back out, interfering with door closure, which can lead to over or under infusion. The current BD pivot latch screw design, which was introduced in 2009, includes retaining microspheres that prevent the screw from backing out when properly installed in accordance with labeling. We are notifying customers to ensure that (1) all pivot latch screws are inspected by hospital staff prior to use of lvp, (2) all loose, backed out, and third-party screws are replaced by the hospital biomed staff with new BD manufactured pivot latch screws in accordance with the labeling, and (3) customers are aware of the risks associated with backed-out pivot latch screws. Recall start date: November 15, 2022
RecallTracker