Recall Z-0288-2016 ยท ITX Transducer, Ultrasonic, Diagnostic
Civco Medical Instruments Co. Inc.
CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 10787043, 11001906, 11001906(CMI), 613-247, 613-247(CMI), 620-116, 639-014, 639-016, 639-021, 639-024, 639-025, 639-026, 639-027, 639-033, 639-035, 639-047, 639-051, 658-001, 667-106, 667-106(CMI), 667-127, 672-001, 698-007, 698-009, 698-013, 698-015, 742-397-T, 742-416, and H
| Date | Nov 17, 2015 (initiated Oct 21, 2015) |
| Status | Terminated |
| Reason | Sterility of the product cannot be assured. |
| Root cause | Process design |
| Action | Civco Medical Solutions sent an Urgent Medical Device Recall letter dated October 19, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all affected needle guides. If the needle guide is contained within a kit, only the needle guide from the kit needs to be returned. The communication contains a response form to be completed and returned by the customer. The customer filling out the response form is asked to acknowledge receipt of the recall notice and indicate the number and type o |
| Quantity | 1139 boxes |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHILE, CHINA (MAINLAND), CHINA (TAIWAN), CZECH REPUBLIC, DENMARK, ECUADOR, FINLAND, FRANCE, GERMANY, HONG KONG, INDIA, ISRAEL, ITALY, JAPAN, KUWAIT, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PUERTO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093713 | ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM Civco Medical Instruments, Jan 19, 2010 |