Recall Z-2440-2021 ยท KXG Applicator, Absorbent Tipped, Sterile
Copan Italia
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 Wrapp
| Date | Sep 9, 2021 (initiated Jul 9, 2021) |
| Status | Terminated |
| Reason | A sterility assurance level of 10-6 cannot be guaranteed due to intentional fraud and data integrity issues at the contract sterilizer, Steril Milano. |
| Root cause | Vendor change control |
| Action | 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 provi |
| Quantity | 3,029,400 units |
| Distribution | US nationwide distribution, including Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.