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04 Feb 2019

CLH Blog - MHRA Field Safety Updates For January 2019

CLH Blog - MHRA Field Safety Updates For January 2019

As always, we have researched the various field safety alerts that have been filed over the past month and have put together a roundup of the most relevant MHRA updates and recalls. These focus on recalls and updates on products and equipment that are relevant to UK care homes and other care 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 is vital that you act on it immediately.

 

Joerns Healthcare have released a notifcation as follows:

Actuator Operational Life Cycle - Technical Bulletin can be read here.

 

ConvaTec - Wide Product Range - Urgent Field Safety Notice

  • Rectal Tubes,
  • Unoversal Drainage Systems,
  • SimpaVac,
  • Sterile Suction Connecting Tubes, 
  • Sterile Connecting Pieces,
  • Suction Handles/Sets (FilterFlow™/Deltaflo),
  • Oxygen Catheters,
  • Sterile Nasal Oxygen Cannulas,
  • Sterile Oxygen Connecting
  • Tubes,
  • Sterile Forceps. 

ConvaTec has voluntarily initiated a recall of specific product codes of the above-mentioned products.
Internal assessment of product packaging integrity has confirmed that these devices are not meeting our
expectations or those of our customers. Transportation testing conducted on the product packaging failed
confirming the potential for a breach in the sterile barrier. Using a non-sterile device on a patient may expose the
patient to infectious agents increasing the patient risk of developing infection.

ConvaTec has not received any reports of incidents related to the packaging seal issue.

FSN Date: 4th January 2019

 

Edwards - Swan Ganz Thermodilution Catheter - Urgent Product Recall 

Affected products: Model Numbers: 131F7, 131F7P, 131VF7P, 151F7

Lot Numbers: 61176373, 61321254, 61176369, 61176314, 61176370, 61176367,
61176374, 61321241, 61311580 

The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine
hemodynamic pressures and cardiac output when used with a compatible cardiac output computer.
Swan-Ganz Thermodilution Catheters are indicated for the assessment of a patient’s hemodynamic
condition through direct intra-cardiac and pulmonary artery pressure monitoring, cardiac output
determination, and for infusing solutions.
The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen
transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization
coefficient, and intrapulmonary shunt fraction.

This non-conformance involves Swan Ganz catheters with incorrect lumen assembly, which causes reversal
of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values and
waveforms. It is possible for unintended treatment due to inaccurate values if the reversal in waveforms is
not noticed. We believe only a small amount of units within the lots identified are impacted.
There were no patient complications reported. 

FSN Date: 4th January 2019

 

Teleflex Medical - Field Safety Notice - Percuvance® Percutaneous Shaft 29cm and Percuvance® Percutaneous Shaft 36cm

Teleflex is voluntarily recalling these products because there is potential for a piece of the distal tip on the
Percuvance® shaft to become deformed and possibly break off during use. If a piece did break off it could
compromise the functionality and security of the tooltip. Should this occur during use, surgical intervention
may be required.

ADVICE ON ACTION TO BE TAKEN BY MEDICAL STAFF:

  1. We request that you check your inventory for product within the scope of this field action. Users should cease use and distribution of stock of the affected product batches and quarantine immediately.
  2. If you do not have stock in scope of this field action as referred to in above table, then mark the according checkbox on the Acknowledgement form (Appendix 1) and return the form to the fax number or e-Mail-address mentioned below.
  3. If you have stock from the affected product as referred to in above table, mark the according checkbox on the Acknowledgement form (Appendix 1). Contact customer service by calling the phone number mentioned below who will issue you with a return number. Write this return number into the respective field in the Acknowledgement form.
  4. Complete ‘Appendix 1’ for all products in your possession and under control. Return this form immediately to Customer Service.
  5. Teleflex (or your local dealer) will issue a credit note upon receipt of the returned affected product. 

FSN Date: 14th January 2019

 

As always, we’ll be back again next month with all of the latest MHRA field safety updates. Seen an alert we’ve missed? Tweet us @CLHGroupLtd to let us know and don’t forget to use '#CommittedToCare' in your posts.

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