Class 4 Caution in Use: EcoLab Klerpack BD Syringe Multi-Pack
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| Class | Class 4 |
|---|---|
| Type | Medicines recall/notification |
| Issued | 14 Sept 2016 |
| Reference | EL (16)A/13 |
Class 4 Medicines Defect Information
Caution in Use
Distribute to Hospital Pharmacy Level
EL number
EL (16)A/13
MDR number
MDR 037-09/16
Company name
EcoLab
Product description
Klerpack BD Syringe Multi-Pack
Brief description of the problem
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.
Download document
Klerpack BD Syringe Multi-Pack EL16 A13
Appendix 1 - Ecolab Field Safety notice
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter.