What we know
Summary Date Recall was issued:Product Name:Manufacturer:Recalling Firm:Batch(es):Manufacturing Date:Expiry Date:Reason for Recall: 8th July 2024Disposet IV Infusion SetDisposafe Health and Life Care Limited, IndiaRowena Healthcare Limited23CD0024April 2023March 2028This recall is necessitated as a result of laboratory analysis conducted on samples of the product by the FDA Centre for Laboratory Services and Research which confirmed that Disposet IV Infusion Set did not comply with requirements for Average Flowrate (ml/min), Drip Chamber and Drip Tube Delivery/g and Flow. This means your product did not comply with the tested requirements of ISO 8536-4:20202. This makes the product substandard and therefore not recommended for the intended use. The use of the medical device therefore presents a public health risk. AnnouncementThis recall is necessitated as a result of warehouse market surveillance conducted at the warehouse. Actual product specification is a powder for oral suspension. The affected batches were caked and not free flowing. This makes the product substandard and therefore not recommended for its intended use.
Safety advice
- Stop using or purchasing the product if the notice asks you to.
- Keep receipts, batch numbers and packaging — they help with returns or investigations.
- Share this alert with anyone who might be affected, especially relatives and colleagues.
- If you believe you’ve been harmed, contact the official source or a relevant authority.