06 Aug 2018

CLH Blog - MHRA Field Safety Updates For July

CLH Blog - MHRA Field Safety Updates For July

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.

Zimmer Biomet - Persona® Partial Knee System Spacer Block Alignment Tower - Field Safety Recall

Zimmer Biomet is conducting a lot specific medical field action (removal) for the Persona Partial Knee (PPK) System Spacer Block Alignment Tower. The PPK Alignment Tower mating feature that mates with the spacer block was found to be undersized, which could potentially lead to mating issues between the devices. There is another option in the surgical technique (1222.4-GLBL-en; page 13) for performing limb alignment without the alignment tower.

Affected products include: 42-5399-006-35 63465803 (01) 00880304809178 (10) 63465803 Persona® Partial Knee System Spacer Block Alignment Tower 42-5399-006-35 63762260 (01) 00880304809178 (10) 63762260 42-5399-006-35 63767434 (01) 00880304809178 (10) 63767434 42-5399-006-35 63799794 (01) 00880304809178 (10) 63799794

FSN date: July 2018

Luminex - ARIES® Systems ARIES®-M12V1-IVD & ARIES®-M6V1-IVD; Hand-Held Barcode Scanner CN-0321-01 /JDK-2330 - Field Safety Notice

When the potentially affected barcode scanner is used on multiple ARIES® cassettes at the same time, the system may prepopulate the “Sample ID” field with a previously stored sample ID. This field will be overwritten by scanning or manually entering a sample, but in the event the ARIES cassette is not scanned, the prepopulated field may cause the incorrect association of sample identification to occur.

To date, our internal investigation has only shown that the firmware version on one hand-held barcode scanner was the incorrect version of firmware approved for use with the ARIES® Systems. Given that the ARIES® System barcode scanner (CN-0321-01 /JDK-2330 Rev B) has the potential to contribute to an incorrect result by creating the possibility that a Patient/Sample ID may be assigned to the wrong cassette, we are voluntarily initiating a recall to ensure no additional handheld scanners have this discrepant firmware. There have not been any adverse events associated with the use of the ARIES® System barcode scanners at this time.

FSN date: 6th July 2018

ConvaTec - AbViserTM AutoValveTM IAP Monitoring Device - Field Safety Notice

ConvaTec has voluntarily initiated a recall of specific product codes of AbViser AutoValve IAP Monitoring Device. Internal assessment of this product’s packaging has confirmed that these devices are not meeting our expectations or those of our customers. Testing conducted on AbViser AutoValve IAP Monitoring Devices confirmed the potential for a pinhole breach in the sterile barrier. Using a potentially non-sterile contaminated device on the patient may expose the patient to infectious agents increasing the patient risk of developing an infection.

AbViser provides a sterile non-invasive disposable intra-abdominal pressure monitoring device containing aspiration tubing, infusion tubing, valves and optional pressure transducers for the measurement of intra-abdominal bladder pressure. The device attaches directly to the patient’s existing urinary catheter/drain system providing both an enclosed fluid path for infusing fluid into the bladder catheter as well as a method for monitoring the hydrostatic pressure in the bladder. Only the identified product codes within this notice are affected. For this reason and to address any potential risk of harm, all of the affected products should not be used. If you believe any affected products remain in your inventory, please contact your Regional contact.

FSN date: July 2018

IPS Specials - Melatonin 10mg capsules - Product Recall

IPS Specials are recalling specific batches of Melatonin 10 mg capsules because they have been assigned an incorrect extended expiry date. Affected batches are batch numbers 171013046 and 171024067 with an expiry date of 9th April 2021 and batch number.

IPS Specials is carrying out a company-led recall of two batches at pharmacy and wholesaler level as they have been labeled with an incorrect extended expiry date of 09 Apr 2021 when they should have been labeled as 26 Dec 2017. Due to a master data error, the product has been inadvertently assigned an extended shelf life in line with that of the active ingredient.

FSN date: 17th July 2018

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

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