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06 May 2019

CLH Blog - MHRA Field Safety Updates For April 2019

CLH Blog - MHRA Field Safety Updates For April 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.

 

Arrow Internatinal - Arrow® PICC and JACC Kits - Product Recall

Description of the problem & immediate actions required:

The lidstock states the incorrect expiration date for the product within. This issue could result in
inadvertent use of a device which is expired. This could potentially lead to various complications,
including biocompatibility issues/toxicity from chemical constituents, allergic reaction/irritancy,
pyrogenicity, reduced antimicrobial efficacy, ineffective treatment, or delay in therapy.

No patient injury has been reported pertaining to this issue. Product code and lot combinations not
referenced in Appendix 2 are not impacted by this recall.

FSN date: April 2019

 

Axis-Shield Diagnostics Ltd - Alere NT-proBNP for ARCHITECT Controls - Product Recall 

Affected products include: 

  • Alere NT-proBNP for ARCHITECT Controls 
  • Alere NT-proBNP for Alinity i Controls 
  • Alere NT-proBNP for ARCHITECT Calibrators 
  • Alere NT-proBNP for Alinity i Calibrators 

All of the lots listed above demonstrate a time dependent, stability drift in results returned from NT-proBNP testing on both the ARCHITECT and Alinity i systems.
Patient samples and quality control results have been confirmed to be acceptable, however, stability modeling tools have predicted unacceptable performance for these material lots prior to the current dating (expiry) assigned. Root cause and corrective action for this issue has not yet been identified, however, as an interim mode of control, all future calibrator and control lots will have shortened expiry dating. 

This issue may generate false positive patient results and invalid results that may go undetected. 

FSN date: April 2019

 

Baxter - Extension Sets - Product Recall

Baxter Healthcare Corporation is issuing a voluntary product recall for the Extension Sets listed below due to a potential sterility breach between the luer and the cap. This
issue was identified during routine product testing. Only sets which were assembled using caps manufactured during a defined period, failed the testing. The affected lots were distributed between July 2014 and October 2018.

Affected Products: 

EMC0062M EXTENSION SET 76CM W/LUERLOCKADAPTOR
EMC9190 CATHETER EXTENSION SET WITH CLEARLINK - MALE LUER LOCK ADAPTER
RMC0055M Y TYPE EXTENSION SET

Baxter has asked that the following steps are taken:

  1. Locate and remove all affected product from your facility. The product code and lot number can be found on the individual product and shipping carton.
  2. Complete the enclosed customer reply form clearly stating your facility name, and return it to Baxter by either faxing it to 01635 206034 or scanning and emailing it to; UK_SHS_FCA@baxter.com, even if you don’t have any inventory. Returning the customer reply form promptly will confirm your receipt of this notification and prevent you from receiving repeat notices.
  3. If you are a dealer, wholesaler, or distributor/reseller that distributed affected product to other facilities, please conduct a recall with your end-user customers in accordance with your customary procedures. 

FSN date: April 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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