Copan Italia Via Francesco Perotti 10 Brescia Italy COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the following reference numbers REF:501CS01, Minitip, sterile Single Wrapped, Molded bp 80mm; REF: 20226, P/N 501CS01Q100, Minitip, Sterile, Single Wrapped, bp 60MM, BUNDLES OF 20 pcs; REF: 501CS01.Q20, P/N 1127700, Minitip Applicator Sterile Ind. wrapped., bp 60mm, bundles of 20; REF: 502CS01, Regular, Sterile single Wrapped, Molded bp 80mm; REF: 503CS01, Flexible, Sterile Single Wrapped, Molded bp 100mm; REF: 220252, Recall

Check Your Product

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

Reason for Recall

As stated by FDA

A sterility assurance level of 10-6 cannot be guaranteed due to intentional fraud and data integrity issues at the contract sterilizer, Steril Milano.

Recommended Action

Per FDA guidance

On July 26, 2021, Copan Italia issued a "Urgent: Medical Device Recall" notification to all affected consignee. In addition to informing consignees about the recall, the firm asked consignees to take the following actions: 1. This notice should be passed on to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. 2. Please identify, segregate, and discontinue use of all affected product included within ATTACHMENT #1_FLOQSwabs Recall product list . 3. Confirm you have read and understood the recall instructions provided in the letter in writing using the FORM #1_FLOQSwabs Recall Return Response , by email, to: Francisco Cuerva, Copan Diagnostics, Inc., 26055 Jefferson Avenue, Murrieta, CA US 92562, Phone: 800 216 4016 Ext. 204, InfoRecall@copanusa.net 4. Disposal must be performed according to local regulation and it does not require biohazard disposal precautions. Evidence or declaration of Product disposal must be returned in writing, using the FORM #2_FLOQSwabs Recall Disposal evidence , by email, to: Francisco Cuerva, Copan Diagnostics, Inc., 26055 Jefferson Avenue, Murrieta, CA US 92562, Phone: 800 216 4016 Ext. 204, InfoRecall@copanusa.net 5.If you are not in the position to identify, segregate or discard the Product you must advise in writing using the FORM #1_FLOQSwabs Recall Return Response , by email, to: Francisco Cuerva, Copan Diagnostics, Inc., 26055 Jefferson Avenue, Murrieta, CA US 92562, Phone: 800 216 4016 Ext. 204, InfoRecall@copanusa.net 6.This recall should be carried out to the end user level for all the affected Products that have been distributed including any products under private labeling, incorporated or utilized as kit components. 7. Any adverse events associated with recalled Product must be communicated in writing using the FORM #1_FLOQSwabs Recall Return Response , by email, to: Francisco Cuerva, Copan Diagnostics, Inc., 26055 Jefferson Avenue, Murri