Gama Healthcare Clinell Universal Wipes (ICN 1282)

Important Customer Notice Recall

Ref: 2021/1282 ICN Number: 1282

Gama Healthcare has issued an update to their Field Safety Notice adding a further four Lot numbers for their universal wipe CW200.

NPC	Product Description	Supplier Code/MPC	Additional Affected Lots
VJT118	Wipe Disinfectant moist 34gsm 200mm x 280mm	CW200	UBV3032520A, UBV3032520B, UBV1032720A, UBV7032720A,

Please see the updated Field Safety Notice and follow the instructions. (see our Downloads ▼ section).

Alert:

Gama Healthcare has issued an urgent Field Safety Notice recalling five Lot numbers of their universal wipe CW200 following routine testing identified low level contamination with Burkholderia cepacian.
Described as ‘opportunistically pathogenic’ B. cepacia poses little medical risk to healthy individuals but can cause serious infections in those with compromised immune systems notably individuals with cystic fibrosis and chronic granulomatous disease.
B. cepacia is a known cause of infections in hospitalised patients, particularly those with weakened immune systems, spread by person to person contact or contact with contaminated surfaces.

Products Affected:

NPC	Product Description	Supplier Code/MPC	Affected Lots
VJT118	Wipe Disinfectant moist 34gsm 200mm x 280mm	CW200	UBV1033020A, UBV2033020A, UBV3033020A, UBV4033020A, UBV6032920A,,

Next Steps:

Gama Healthcare has written, see attached, to Medical Safety Officers and Infection Control Leads with full information on this issue.
Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
Where affected lot numbers are found, withdraw from use and destroy in accordance with your local regulations.
Inform quantities destroyed to Gama Healthcare at Regulatory@gamahealthcare.com.
Contact your local NHS Supply Chain Advisor with full details including written confirmation of product destroyed to enable us to manage your credit.
NHS Supply Chain depots’ stock has been checked and all future issues will be of unaffected lot numbers.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.

MHRA: 2021/005/005/601/530

Recall: 21

Alert:

Gama Healthcare has issued an urgent Field Safety Notice recalling five lot numbers of their universal wipe CW200 following routine testing identified low level contamination with Burkholderia cepacian.
Described as ‘opportunistically pathogenic’ B. cepacia poses little medical risk to healthy individuals but can cause serious infections in those with compromised immune systems notably individuals with cystic fibrosis and chronic granulomatous disease.
B cepacia is a known cause of infections in hospitalised patients, particularly those with weakened immune systems, spread by person to person contact or contact with contaminated surfaces.
The batches identified were manufactured in July 2020 and were distributed between 11 September and the end of December 2020.

Products Affected:

NPC	Product Description	Supplier Code/MPC	Affected Lots
VJT118	Wipe Disinfectant moist 34gsm 200mm x 280mm	CW200	UBV1033020A, UBV2033020A, UBV3033020A, UBV4033020A, UBV6032920A,

Next Steps:

Gama Healthcare has written, see attached, to Medical Safety Officers and Infection Control Leads with full information on this issue.
Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
Where affected lot numbers are found withdraw from use and destroy in accordance with your local regulations.
Inform quantities destroyed to Gama Healthcare at Regulatory@gamahealthcare.com.
Contact your local NHS Supply Chain Advisor with full details including written confirmation of product destroyed to enable us to manage your credit.
NHS Supply Chain Depots’ stock has been checked and all future issues will be of unaffected lot numbers.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.

1282 Gama FAQ's
A PDF of the FAQ's for ICN 1282.
1282 Gama Updated Field Safety Notice
A PDF of the Field Safety Notice for ICN 1282.