Disposet IV Infusion Set

Summary

Date Recall was issued:
Product Name:
Manufacturer:
Recalling Firm:
Batch(es):
Manufacturing Date:
Expiry Date:
Reason for Recall:
8th July 2024
Disposet IV Infusion Set
Disposafe Health and Life Care Limited, India
Rowena Healthcare Limited
23CD0024
April 2023
March 2028
This 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.

Announcement

This 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.