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Medical Device Quality Alert: Class II Medical Device Recall of Sigmaflex Latex Examination Gloves (Powdered) Batch No. 20231012 Manufactured by A1 Globe Sdn. Bhd., Malaysia.

The Pharmacy and Poisons Board has mandated Bakpharm Ltd to initiate an urgent recall of Sigmaflex Latex Examination Gloves (Powdered) Batch No. 20231012 Manufactured By A1 Globe Sdn. Bhd., Malaysia.

From: Pharmacy and Poisons Board

Published: 22nd October 2024

Recall Reference Number: REC/2024/029

Recall Classification: Class II

Recall Level: Retail/Facility Level

Manufacturer: A1 Globe Sdn. Bhd., Malaysia

Local Technical Representative: Bakpharm Ltd

Product name: Sigmaflex Latex Examination Gloves

Active Pharmaceutical Ingredient: Latex Examination Gloves (Powdered)

Affected counties: All

Affected Batch

Batch Number

Date of Manufacture

Date of expiry

Pack Size

20231012

10/2023

09/2028

100s

Brief description of the problem

The Pharmacy and Poisons Board (the board) received a market complaint on Sigmaflex Latex Examination Gloves (Powdered) Batch No. 20231012 Manufactured by A1 Globe Sdn. Bhd., Malaysia. Subsequently, the Board performed an analysis (Water Tightness test) of the complaint samples, and an out-of-specification (OOS) result was obtained.

Action for healthcare professionals

Quarantine all remaining stock and stop further distribution, sale, issuing or use of the above batch. Await contact from Bakpharm Ltd to arrange the return.

Action for patients and caregivers

No further action is required by patients and caregivers as this is a Retail/hospital Pharmacy and Wholesaler/Distributor level recall.

Further Information

For enquiries about consignments of the impacted batch, please contact Bakpharm Ltd at: preet@bakpharm.com Tel: +254 20 8042880/5/6/7, +254 722 777400

You are advised to promptly report any case(s) of adverse events and suspected substandard and falsified products to the nearest healthcare facility or through the following channels:

For any further enquiries and feedback on the product recall, kindly contact the post-marketing surveillance unit of The Pharmacy and Poisons Board Kenya “the Board” via email at pms@ppb.go.ke and Recall Feedback Form

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Medical Device Quality Alert: Class II Medical Device Recall of Sigmaflex Latex Examination Gloves (Powdered) Batch No. 20231012