04 May 2017

CLH Blog - MHRA Field Safety Updates For April

CLH Blog - MHRA Field Safety Updates For April

As always, we’ve scoured many field safety alerts that have been filed over the last month (April 2017) and have put together a roundup of all the most relevant MHRA updates and recalls. These focus on updates for health care products and equipment that are relevant to UK care homes and other health facilities.

Please note that the updates mentioned below are all things listed with the Medicines and Healthcare products Regulatory Agency (MHRA) amongst other suppliers. Please also note that if you receive a field safety notice from a supplier, it’s important to immediately act on it.


All Alaris™ GS, GH, CC, TIVA, PK, Enteral Syringe Pumps, and, Asena™ GS, GH, CC, TIVA, PK, Syringe Pumps – risk of uncontrolled bolus of medicine

Manufactured by CareFusion/BD Medical – identify and replace broken backplate spring in the plunger assembly and note updated preventative maintenance schedule for these pumps

Identify all devices with the product codes listed in the Field Safety Notice
Ensure hospital or Carefusion service specialist checks pumps as detailed in the FSN
Prioritise devices used in paediatric/neonatal/critical care areas and all devices more than three years old
Ensure hospital or CareFusion replace broken springs
Ensure all syringe pumps are regularly maintained and serviced in accordance with the manufacturer’s updated preventative maintenance
Note that this alert replaces MDA/2017/003 from February 2017

Deadlines for actions
Actions underway: 15 May 2017
Actions complete: 12 July 2017

Device details
Product Name: Alaris™ GS, GH, CC, TIVA, PK, Enteral Syringe Pump Product codes with prefix (all variants): 8001, 8002, 8003, 8004, 8005, 8007
Product Name: Asena™ GS, GH, CC, TIVA, PK Syringe Pumps Product codes with prefix (all variants): 8001, 8002, 8003, 8004, 8005



BD Plastipak 100ml catheter tip syringe with Luer slip adaptor, specific lots – risk of leakage and delayed therapy

Manufactured by Becton Dickinson (BD) – product recall due to leak around the stopper which can result in under-dose or exposure of clinicians or patients to cytotoxic drugs.

Identify all lots of syringes that have an expiry date up to and including April 2021.
Ensure all users are aware of the manufacturer’s Field Safety Notice published in February 2017.
Contact the manufacturer to acknowledge the FSN and arrange to return affected syringes for replacement.

Deadlines for actions
Actions underway: 16 May 2017
Actions complete: 31 May 2017

Device details
BD catalogue number: 300605



Taizhou Xinkang Medical Materials: Wound Dressing

We have been informed that there was a product symbol issue. The affected products were labeled as 'wound dressing', the category of CE certificate includes 'sterile guaze bandages', while it doesn't specifically say it includes 'wound dressing'.

MHRA reference: 2017/004/007/299/025


Wilson Frame Pads - a variance discovered in the construction of the pads

The model 5319-37 pads may allow the patient to contact the underlying carbon fiber structure of the Wilson Frame and could lead to a pressure injury.

You will be provided with a replacement set of model 5319-36 Gel Pads.

Field Safety Notice


Maxter Catheters: ENTRAL ENFit™ nasogastric feeding tubes - Ranges NST, SFT, AND DFT

Enteral Feeding Devices - Maxter Catheters has issued an urgent field safety notice regarding selection and use of the correct size and length of naso gastric enteral enfit feeding tubes following feedback from a customer.

It has been brought to our attention that choosing the correct nasogastric feeding tube - ranges NST, SFT, and DFT, for the appropriate patient group can be difficult for users.

The associated risk is to use a tube with an inappropriate length of centimetre marks on the tube and as a consequence the centimetre marks are out of range which could potentially to lead to insufficient or excessive tubing.



Medicina Hypodermic Concentric Luer Lock 5ml Syringe - precautionary recall

Medicina has issued a precautionary recall for one lot number of their IVL05 5ml luer lock IV syringe following a report of a defect in the printing on the syringe.

There is the potential for less volume of medication than intended being delivered.
Further investigation confirms only one batch number is affected 160822-05.



Vascular Solutions: Venture RX Catheter, Venture OTW Catheter, and Venture CS Catheter

Vascular cannula and catheters

Model: 5820, 5821, 5822

VSI has concluded there is a potential for excess material used to manufacture the catheter to be present within the inner lumen of the distal catheter tip. It is possible that the excess material may separate from the catheter during a procedure, posing a potential risk of an embolism to the patient.

MHRA reference: 2017/005/008/291/019


Please note this is a summary of alerts for information only, please browse the Medicines and Healthcare products Regulatory Agency (MHRA) website for more. If you receive a field safety notice (FSN) from a manufacturer you must always act on it and if you have a question about a particular FSN, please contact the manufacturer.

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