Field Safety Notice Medline Sterile Surgical Procedure Drapes and Sterile Drape Packs (ICN 3000)

NHSSC: 43

Alert:

• Medline has issued a Field Safety Notice recalling specific lot numbers of surgical drapes and drape packs following a visual inspection finding a small hole near the seal of the header bag pouch, close to the Tyvek portion of the pouch.
• Damaged packaging can compromise the sterility of the product. If holes in the packaging were to go unrecognized, there is an increased risk of infection.
• Additionally, there is a potential risk for a non-sterile device to be placed within the sterile field or a nonsterile device to be used within a sterile procedure. This could lead to contamination of a sterile field and/or a potential risk for patient infection to occur.

Products Affected:

• Affected lots of four products have been supplied by NHS Supply Chain:

• Please note only the lot numbers quoted in the Field Safety Notice are affected.
• Please note other products listed in the notice are available from NHS Supply Chain. The supplier has confirmed that the affected lots of these products have not been supplied via our route.
• Medline advise products that have green stickers are not impacted by this recall and can safely be used. These products with a green sticker, which belonged to the batches involved in this FSN, have been inspected or reworked using another source of sterilization bag to ensure their compliance.
• All NHS Supply Chain stock has been checked and affected products quarantined.
• Future orders will be fulfilled with unaffected stock.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Cease use and quarantine all affected product.
• Complete the Customer Response Form, found on page 3 of the notice and return to GMB-EU-FSN-FSCA-KLEVE@medline.com
• Contact your local NHS Supply Chain Customer Services Advisor with full details of the affected products in your possession, including product codes, lot numbers and quantity. Your Customer Services Advisor will give you a unique CMS log number.
• Dispose of the affected products in accordance with your local regulations. Upon written confirmation of disposal in the form of an email, quoting the CMS reference, your Customer Services Advisor will raise the appropriate credit if a replacement is not agreed with the supplier.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Hospital Care team.

Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.