|DRAP Alert No||No I/07-23-28|
|Action Date||27th July, 2023|
|Target Audience||· Healthcare Professionals particularly working in the critical care areas of hospitals including Physicians, Pharmacists, and Nurses.|
· Procurement Officers at Hospitals and Healthcare Institutions.
· Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores.
|Problem / Issue||Central Drugs Laboratory, Karachi received samples of Surgee Disposable Infusion Set manufactured by the M/s Rehman Rainbow (Pvt) Ltd , Industrial Estate, Kot Lakhpat, Lahore for testing. CDL has declared the sample as substandard based on the analysis for not complying the sterility criteria. Accordingly, the manufacturing company had been directed to recall all the defective product from the market.|
Therapeutic Goods Affected:-
|Product Names||Product Description||Batch No||Manufacturer|
|Surgee Disposable Infusion Set|
Mfg Lic No 000510
Reg No 071602
|Intravenous Infusion set||Batch No IV0523|
Mfg date 05.2023
|M/s Rehman Rainbow (Pvt) Ltd Lahore|
|Risk Statement:||Use of Non sterile IV set poses a serious risk of patient harm and due to non-sterility can lead to bacteremia and sepsis.|
|Action Initiated||-The manufacturing company has initiated a recall of the affected lots of defective products from the market where it was distributed.|
-All healthcare professionals working in critical care units of hospitals as well as pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these lots of the product. The remaining stock should be quarantined and returned to the supplier/company.
-Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or through phone at +92 51 910 73 17, or by Email at gsms∂dra.gov.pk.
-Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
|Advice for Healthcare Professionals||DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these defective lots of the Medical Device. |
-Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link.
-Please click here for further information on problem reporting to DRAP.
|Advice for Consumers||-Consumers should stop using this product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this Medical Device.|
-All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.