MEDLINE INDUSTRIES, LP - Northfield BAUSCH + LOMB EYE MUSCLE, REF VAL036EMESB recall — FDA Z-0159-2023
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
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Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point needles, which may…
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Unable to charge the battery pack- battery packs will allow the batteries to be charged if the voltage of any cell is below 2.5V. When this occurs, the battery pack will not accept the…
Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler,…
During needle withdrawal, the tip shield may prematurely separate from the catheter adapter and preventing the needle tip from being in the safely shielded (leaving the needle tip exposed).
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant.…
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Detachment controller, of an aneurysm embolization system, has an out of specification tunnel opening dimension, which may prevent the implant device pusher from being fully inserted into…
Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler,…
Premature pump failure may lead to the device displaying a HALT 4 error, from which the device cannot recover even after device reboot. The issue may potentially lead to delayed treatment…
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.
the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irrigation path with cellulose fibers that can cause 1) Failure of initial flushing inspection,…
the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
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