This alert is an update to our:
We're continuing to investigate and take action on the potential contamination of some saline products with Ralstonia pickettii. This is occurring with assistance and input from local health departments.
Recall of saline products
Following further investigation, certain batches of previously quarantined saline products are now being recalled. See the recall notice for more information.
Quarantine of other saline products
As a precautionary measure, we have now quarantined all batches of one other sodium chloride 0.9% product. This product is manufactured in the same facility, Legency Remedies Private, as the other recalled and quarantined 30mL ampoules:
Aerowash Eyewash and Wound Irrigation (15 mL & 30 mL) irrigation fluid, medical / surgical procedure; sponsored by Aero Healthcare Pty Ltd and supplied as single product or as part of first aid kits or surgical procedure packs -
- ARTG ID: 159438
- Product Codes: AW1000, AW1060, AW3010, AW3030
- Multiple batches
15mL ampoules
30mL ampoules 23136001E
23136002E
23136003E
23136004E
23136005E
23136006E
23136007E
23136008E
23136009E
23136010E
23136011E
23136012E
23136013E
23136014E
23136015E
23136016E
23136017E
23136018E
23136019E
23136020E
23136021E
23136022E
23136023E
23136024E
23136025E
23136026E
23136027E
23136028E
23136029E
23136030E
23136031E
23136033E
23136034E
23136035E
23136039E
23136048E
23136049E
2386019E
2386020E
2286033E
Quarantine lifted for other saline products
The quarantine of the four batches of sodium chloride 0.9% 10mL ampoules supplied by Interpharma, described in our Safety alert: potential contamination of some saline products with Ralstonia pickettii is now lifted and these products can be returned to the supply chain.
Further testing has not identified R. pickettii in these products and no R. pickettii cases have been reported as associated with their use.
Related links
Safety alert: potential contamination of some saline products with Ralstonia pickettii