Waterborne bacteria, such as R. pickettii, have the potential to contaminate healthcare products. In individuals with compromised immune systems, R. pickettii can lead to opportunistic infections. It is important to note that cases of R. pickettii in the UK are rare and, as of 3 April 2024, three cases of R. pickettii have been confirmed, with a small number of other cases under investigation.
The confirmed infections occurred in individuals who have multiple underlying health conditions and compromised immune systems. All confirmed cases received treatment and recovered but as a precautionary measure against this, the company has recalled all 0.9% sodium chloride solutions intended for irrigation manufactured between April and November 2023.
You should:
- Review your inventory of 0.9% sodium chloride solutions intended for irrigation and determine if any of the batch numbers listed below are present in your stock
- Check any clinical equipment packs or first aid kits that might contain any of the 0.9% sodium chloride solutions and determine if any of the batch numbers listed below are present in these packs
- Immediately stop use, quarantine and stop supply of any identified product(s)
- Where possible, contact any customers who have received or may have received the affected product(s) and ask them not to use the product(s) and to return them to the original place of purchase
- Follow the actions set out in the Field Safety Notice Product Recall.
There are specific reporting arrangements for healthcare professionals to follow in each region. Healthcare professionals should report incidents:
- In England and Wales to the Yellow Card scheme or via the Yellow Card app
- In Scotland to Incident Reporting & Investigation Centre (IRIC) and their local incident recording system
- In Northern Ireland to the Northern Ireland Adverse Incident Centre and their local incident recording system.
Alternative sodium chloride 0.9% solution products are readily available for use in irrigation. Suppliers of these products have been contacted and have confirmed there is adequate supply in the market to support the recall of affected Legency batches.
The batches affected are:
Sodium Chloride Irrigation Solution 0.9 % w/v 20 ml (Blue Dot) – 20mil and manufactured in June 2023 with an expiry date of May 2028 with the following reference numbers:
- 2358022E
- 2358023E
- 2358024E
- 2358025E
- 2358026E
- 2358027E
- 2358028E
- 2358029E
- 2358030E
- 2358031E
- 2358032E
- 2358033E
- 2358034E
- 2358035E
- 2358036E
Sodium Chloride Irrigation Solution 0.9 % w/v 20 ml (Blue Dot) – 20mil and manufactured in June 2023 with an expiry date of June 2028 with the following reference numbers:
- 2358041E
- 2358042E
- 2358043E
- 2358044E
- 2358045E
- 2358046E
- 2358047E
- 2358048E
- 2358049E
- 2358050E
- 2358051E
- 2358052E
- 2358053E
- 2358054E
- 2358055E
- 2358056E
Sodium Chloride Irrigation Solution 0.9 % w/v 20 ml (Blue Dot) – 20mil and manufactured in October 2023 with an expiry date of September 2028 with the following reference numbers:
- 2358069E
- 2358070E
- 2358071E
- 2358072E
- 2358073E
- 2358074E
- 2358075E
- 2358076E