Teleflex—Pilling Knife Handles: Slot Depth May Be Out of Specification
October 11, 2017 | Strategic Insights for Health System
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ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Devices Alerts(HDA). For more information about HDA, contact us at clientservices@ecri.org.
In a September 26, 2017, Urgent Medical Device Recall 1st Notification letter submitted by an ECRI Institute member hospital, Teleflex states that the slot depth of the above knife handles may be out of specification, potentially causing blades not to fit properly. Teleflex also states that this may cause users to struggle to connect the two pieces, potentially causing them to slip and cut their hand. Teleflex further states that if the blade is not securely connected when used in surgery, the blade may dislodge during use and may fall into the body cavity. Additionally, Teleflex states that it has received no reports of patient harm associated with this problem. The manufacturer has not confirmed the...