SafeScraper Curve Twist (Meta C.G.M.) – Sterility Issues (2021)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Sterility issues; single use devices labeled as sterile may not have been adequately sterilized

Recommended Action

Per FDA guidance

On April 26, 2021 C.G.M. S.p.A. sent a "Urgent Field Safety Notice" to all affected consignees via email. On May 10, 2021, the firm followed up this communication with an "Urgent: Medical Device Recall" notification to all affected consignee. In addition to informing the customers about the recall, the firm asked consignees to take the following actions: 1. Stop the use of all devices in your possession that have the lot number listed in Attachment 1 2. Circulate this medical device Recall Notice to everyone in your organization who need to be informed; 3. Identify and segregate all items listed in Attachment 01, if still available on the premises. 4. Fill in the Medical device Recall Return REsponse (acknowledgement and receipt form), including the number of received devices, used or sold devices, remaining and segregated devices 5. If the product has been distributed, identify these facilities and immediately submit this notification. 6. Within 20 working days from receiving the official notification, return involved items to the distributor. 7. Within 30 working days from receiving the official notification, the distributor shall return involved items to manufacturer C.g.M. spa divisione medicale META 8. Contact Information for Distributor: C.G.M. spa divisione medicale META Days/Hours Available for call: Monday -Friday, 9:00 AM to 4:30 PM, European Time (UTC/GMT +2 h) Email Address:helpdesk@metahosp.com 9. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch adverse Event Reporting program either online, by regular mail or by fax.

Distribution

As reported by FDA

FL, IN, TX