Class I - Dangerous
There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.
Oscor
36 recalls • • Categories: Other Medical Devices, Surgical Instruments, Implants & Prosthetics
Class I - Dangerous
Potential for open seal on sterile product
During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system.
The Reusable Oscor ATAR extension cables could separate from the connector during use.
The Reusable Oscor ATAR extension cables could separate from the connector during use.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Class I - Dangerous
Oscor, Inc. in Palm Harbor, FL is recalling myocardial heart wires, models TME60S, TME64S, TME64C, TME64S-3, TME65S, and TME66S. The recall was initiated due to the spacing between anchoring zig-zag to electrode is out of specification.