46. Recall Alert: Substandard Cikina Umblical Cord Clamp

Farooq Aslam Recall Alerts October 27, 2026October 27, 2026Recall

Recall Alert


	MEDICAL DEVICES DECLARED (CIKINA UMBLICAL CORD CLAMP SUBSTANDARD BY DRUG TESTING LABORATORY PUNJAB, Rawalpindi

DRAP Alert No	N^oI/S/10-26-46
Action Date	27 October, 2026
Target Audience	– National Regulatory Field Force – Healthcare Professional – Physician, Pharmacist, and Nurses at hospitals – General Public
Problem / Issue	Drug Testing Laboratory Punjab, Rawalpindi has informed Drug Regulatory Authority of Pakistan that samples of the below-mentioned medical device have been declared “Substandard” on the basis of Sterility Testing.

Sr. No.	Product Name	Name of Manufacturer/Importer	Batch Number	Remarks
1	CIKINA UMBILICAL CORD CLAMP (UMBILICAL CORD CLAMP) MDIR: 0003486	M/s Ningbo Greatcare Trading Co. Ltd, China; Marketed by: Al-Hamd Enterprises, FL-11/1/1, Block 6, Gulshan e Iqbal Karachi Karachi (ELI # 00285)	25495	The sample is SUBSTANDARD on the basis of Sterility test.

Therapeutic Goods (s) Affected: –

Risk Statement:	The sterility failure of the umbilical cord clamp may result in exposure of neonatal patients to microbial contamination. Due to the vulnerable patient population, inability of the user to detect the defect, and potential for serious infection including sepsis, the residual risk is considered unacceptable and requires immediate corrective and regulatory action.
Action Initiated	The field force of DRAP and Provincial Drug Control Departments have been asked to immediately conduct market surveys for detection of presence and removal of the affected batches from the market. Manufacturers, importers and distributors have been directed to initiate recall of the affected batches in accordance with applicable regulatory requirements.
Advice for Healthcare Professionals	DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by batches of mentioned products. Adverse reactions or quality problems experienced with the use of above mentioned batches of the drug product are to be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link. Further information of reporting problems to DRAP is available on this link.
Advice for Pharmacies/Medical stores: –	All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying the above-mentioned batches. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units should also increase surveillance in the market to ensure effective recall of the affected products.
Advice for Consumers	Consumers and healthcare facilities in possession of the affected batches should immediately stop using the above-mentioned products and contact the supplier, distributor or manufacturer for return or replacement. Any adverse event or quality issue associated with the use of these products should be reported to DRAP/National Pharmacovigilance Centre.