Ecolab are recalling batches of Klerpack BD Syringe Multi-Pack as the sterile packaging may contain small holes in the film of the pouch. If holes are present, the package integrity is compromised and there is a risk that the syringe may no longer be sterile. The affected syringe products and batches are listed in Appendix 1 (Ecolab Field Safety notice).
Advice for healthcare professionals
The objective of this Drug Alert is to make users of the syringes aware of the Field Safety Notice in order to:
Quarantine affected stock of the syringes
Perform a local risk assessment for unexpired medicinal products produced using the affected batches of syringes
The local risk assessment should take into account the following factors:
Specific use of the syringe (such as use during the manufacturing/compounding process and/or the final closed container system)
Nature of the medicinal product (such as expiry period; susceptibility to microbiological proliferation, or any inhibitory effect)
Route of administration and patient population
Likelihood of medicinal product shortage (is replacement stock or an alternative product available?); impact of shortage on patients
Ecolab data indicates a high likelihood of syringe packaging being compromised. The holes cannot be detected visually.