The FDA has alerted healthcare suppliers to not use Cardinal Health (NYSE:CAH) Monoject syringes with syringe pumps and patient-controlled analgesia, or PCA, pumps till it additional evaluates stories of incompatibility.
Cardinal started distributing Cardinal Health-branded Monoject syringes in June. The new syringes, nevertheless, have totally different dimensions than the corporate’s older Covidien-branded Monoject syringe line, which was made by a special producer.
The FDA stated the adjustments in dimensions might trigger the PCA pumps to malfunction, which might end in an overdose, underdose, delays in remedy or delays in occlusion alarms, in accordance with an announcement.
The company stated healthcare suppliers can nonetheless use Covidien-branded Monoject syringes with syringe pumps or PCAs. The company famous, nevertheless, that the syringes should not have the model printed on the syringe itself and suggested healthcare suppliers to maintain the outer packaging for verification functions.
In September, Cardinal issued a product correction recall for Cardinal Health Monoject single-use Luer-lock tip syringes, advising that they shouldn’t be used with syringe pumps.
On Monday, the company stated it was involved that info supplied by Cardinal “has not sufficiently mitigated the risk of incompatibility” when the syringes are used with different pumps reminiscent of PCAs.
The FDA added it had considerations that the danger of incompatibility might apply to different sizes of Cardinal Health Monoject syringes and was working with the producer to deal with the matter.
The company stated that whereas it has obtained over a dozen stories involving delayed or inaccurate remedy related to the Cardinal Health Monoject syringes, it isn’t conscious of any deaths.