Important Safety Alerts

The Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom posted a medical device safety alert concerning Metalline wound, drainage, tracheo dressings manufactured by Lohmann & Rauscher GmbH & Co.KG.

The affected devices are identified as follows:-

• Metalline Woung dressing 5/10 1Stk gero, reference number 23080, lot number 605212315
• Metalline wound dressing 10x12 50ste, reference number 23082, lot number 550512208
• Metalline wound dressing 10x12 10ste, reference number 23084, lot number 550512208
• Metalline Drain-K Kruetten 6x7 8000Stk, reference number 23088, lot number 551412208
• Metalline 6x7 50ste, reference number 23093, lot numbers 603212208, 606412208, 609212208 and 614312208
• Metalline Tracheo 8x9ste, reference number 23094, lot numbers 606512208, 609412208 and 614512208

During the quality control process parts of needles or whole needles were detected on or in the backfacing nonwoven of some final products. The needles are from the needling process during manufacturing of the backfacing nonwoven, which are usually detected by a metal detector and separated.

The probably affected products were immediately separated and the affected batches were blocked in the warehouse. Until today, the manufacturer has not received any complaints from the market.

However, as the manufacturer can not completely exclude that products with metal needles have already been delivered to customers, they decided to perform a precautionary recall of the products in terms of patient safety.

For details, please refer to the MHRA website:
https://mhra.filecamp.com/public/file/2f9u-cu61nscs

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 21 June 2016