Grandbrothers
The FDA has alerted healthcare providers not to use Cardinal Health (NYSE:CAH) Monoject syringes with syringe pumps and patient-controlled analgesia, or PCA, pumps until it further evaluates reports of incompatibility.
Cardinal began distributing Cardinal Health-branded Monoject syringes in June. The new syringes, however, have different dimensions than the company’s older Covidien-branded Monoject syringe line, which was made by a different manufacturer.
The FDA said the changes in dimensions could cause the PCA pumps to malfunction, which could result in an overdose, underdose, delays in therapy or delays in occlusion alarms, according to a statement.
The agency said healthcare providers can still use Covidien-branded Monoject syringes with syringe pumps or PCAs. The agency noted, however, that the syringes do not have the brand printed on the syringe itself and advised healthcare providers to keep the outer packaging for verification purposes.
In September, Cardinal issued a product correction recall for Cardinal Health Monoject single-use Luer-lock tip syringes, advising that they should not be used with syringe pumps.
On Monday, the agency said it was concerned that information provided by Cardinal “has not sufficiently mitigated the risk of incompatibility” when the syringes are used with other pumps such as PCAs.
The FDA added it had concerns that the risk of incompatibility could apply to other sizes of Cardinal Health Monoject syringes and was working with the manufacturer to address the matter.
The agency said that while it has received over a dozen reports involving delayed or inaccurate therapy associated with the Cardinal Health Monoject syringes, it is not aware of any deaths.