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Strathclyde Pharmaceuticals Ltd is recalling a single batch of Xarelto 20mg film-coated tablets (Rivaroxaban) because of reports of rogue blister strips of 15 mg tablets within two packs of 20 mg tablets.
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(Focus Pharmaceuticals) Error with the barcodes on selected batches of 8 medicinal products – Class 4 Caution in Use (EL (17)A/08)
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Torrent Pharma (UK) Ltd is recalling the below batches as a precaution because out of specification results for dissolution were obtained during routine stability testing.
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Baxter Healthcare Limited are initiating a precautionary, company-led, ward-level recall of two batches of Sodium Chloride Infusion 0.9% w/v 1000 mL bags due to a potential leak with the bags.
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Pharmacy and wholesaler level recall of two batches of Parallel Imported One-Alpha Drops x 10 ml because the dropper included in this pack delivers 0.05 micrograms of alfacalcidol instead of 0.1 micrograms as labelled on the…
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Manufactured by Philips Healthcare – two battery related problems: 1) may fail to power on or reboots repetitively, 2) after unplugging from AC mains, may fail to deliver a shock or undertake pacing.
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Manufactured by Physio-Control – risk of unexpected device shutdown due to an intermittent connection between the battery and device contacts.
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All Alaris™ GS, GH, CC, TIVA, PK, Enteral Syringe Pumps, and, Asena™ GS, GH, CC, TIVA, PK, Syringe Pumps – risk of uncontrolled bolus of medicine
Manufactured by CareFusion/BD Medical – identify and replace broken backplate spring in the plunger assembly and note updated preventative maintenance schedule for these pumps
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Manufactured by Dräger – ventilator may stop working if oxide layers accumulate due to the infrequent use of the control knobs (potentiometers).
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Action within 48 hours: Novo Nordisk Ltd. is recalling seven batches of GlucaGen HypoKit due to a small number of needles being detached from the syringe.
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CME has recommended the need for protection of these pumps when exposed to direct sunlight.
In addition, due to connector leakages, the manufacturer is recalling extension sets (specific product codes and batches) used with…
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(CooperSurgical under different brand names) Risk of serious burn if device is used past its expiry date (MDA/2015/025)
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(All manufacturers) Low risk of Mycobacterium infection in patients undergoing cardiac surgery, associated with heater-coolers used with cardiopulmonary bypass machines. Possible cause may be Mycobacterium-contaminated water…
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(Boston Scientific) Rapid battery depletion leads to risk of loss of therapy. (MDA/2014/039)
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(All manufacturers) Delays in acting on field safety notices can compromise patient safety (FSNs). (MDA/2014/037)
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(Various manufacturers) Risk if alarms are ignored or damaged breathing systems are used. (MDA/2014/020)
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(Medtronic) Risk due to incorrect selection and delivery of bolus amount. (MDA/2014/019)
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(Pace Medical Inc) CE-marking suspended due to quality system failings. (MDA/2014/015)
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This alert has been issued as B. Braun Melsungen AG has informed us that during regular visual inspection of retained samples of Sodium Bicarbonate solutions with bromobutyl stoppers precipitation in solution was observed. …
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(Hospira) Use an alternative pump, where available. (MDA/2013/078)
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(All manufacturers and models) Can lead to potential periods of asystole, syncope and possible death. (MDA/2013/032)
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(All models and manufacturers) Be aware of the various maximum implant durations for safe retrieval for each IVC filter model. (MDA/2013/028)
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(All manufacturers) Ensure detergent and disinfectant wipes are compatible with the device. (MDA/2013/019)
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(Hospira) Due to pump faults. (MDA/2013/016)
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(Hospira) If pump is running on mains power and software detects that battery cannot be fully recharged, an alarm will sound and infusion will stop. (MDA/2013/006)
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(Various manufacturers) Leads to dislodgement of the tube with subsequent risk of airway loss. (MDA/2012/062)
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(Invacare) Should be appropriately decontaminated between each patient use. (MDA/2012/038)
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(All manufacturers) foam heads of oral swabs may detach from the stick during use, which may present a choking hazard for patients. (MDA/2012/020)
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(GE Healthcare) accidental incorrect setting of the ACGO switch results in no fresh gas flow to the patient.(MDA/2011/108)
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(All manufacturers) some pre-filled glass syringes are incompatible with some needle-free connectors; and when adaptor stays attached after use there is a possible risk of infection and or air embolus to patients. (MDA/…
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(Hospira Inc) audible alarm on listed Plum A+ infusion pumps may fail, which could cause a delay or interruption to treatment. (MDA/2011/066)
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(All manufacturers) inflammatory or granulomatous mass formation at the catheter tip causes a risk of temporary or permanent neurological impairment. (MDA/2008/038)
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(St Jude Medical) potential reduction in number of shocks (skipped charge) delivered per therapy episode and inappropriate rate responsive pacing for up to 90 minutes. (MDA/2005/045)