CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO
This recall has been terminated (originally issued July 30, 2018).
- Recall Initiated
- July 30, 2018
- Terminated
- September 16, 2020
- Recall Number
- Z-2946-2018
- Quantity
- 107 units
- Firm Location
- Kalona, IA
- Official Source
- View on FDA website ↗
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.
Distribution
United States, Austria, Belgium, Denmark, France, Germany, Poland, Spain, Switzerland and United Kingdom
Lot / Code Info
UDI 00841436107327, Lot numbers: A018067, A018067, A021026, A021026, A021226, A021226, A021226, A022447, A022447, A023876, A023876, A025137, A025137, A025137, A025137, A02560, A025606, A025606, A025606, A026609, A026609, A026609, A026609, A026610, A026610, A026610, A028159, A028159, A028645, A029293, A029293, A029293, A029383, A032036, A032036, A032036, A032036, A032036, A032036, A033139, A033139, A033139, A033139, A033153, A033153, A035009, A035009, A035009, A035010, A035010, A035010, A035010, A035010, A035568, A035568, A037150, A037231, A037231, A037231, A037585, A037585, A039417, A039417, A040376, A040376, A040839, A041444, A041444, A041444, A041723, A041723
Root Cause
Process control
Action Taken
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 order@civco.com