CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO
FDA Recall Z-2947-2018 · Posted None
Recalling FirmCivco Medical Instruments Co. Inc.
Recall StatusTerminated
Product CodeITX
Date Initiated2018-07-30
Date Terminated2020-09-16
Product Quantity3 units
Reason for Recall
The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide.
Firm Action
The firm initiated communication on 07/30/2018 by email and telephone calls. The firm requested return of the recalled product.
Questions may be made to the Account Representative by calling CIVCO Medical Solutions, Multi-Modality Imaging at 800-445-6741 or 319-248-6757 7:00 AM - 5:30 PM CST or by email at [email protected]
Root Cause
Process control
Distribution Pattern
United States, Austria, Belgium, Denmark, France, Germany, Poland, Spain, Switzerland and United Kingdom
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.