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FDA (Device enforcement)Recalled 2018-07-30closedclass ii

Civco Medical Instruments Co. Inc.: CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO

Is my product affected?

CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO

  • UPC 00841436107327

Check against the official notice below — it lists the full affected range.

What happened

Civco Medical Instruments Co. Inc. is recalling 107 units of CIVCO Needle Guide (REF 676-144, sterile, in quantities of 24) that were distributed across the United States, Austria, Belgium, Denmark, France, Germany, Poland, Spain, Switzerland, and the United Kingdom. The needle guides were found to have either missing adhesive or inadequate adhesive to properly hold the assembled cannula in place on the needle guide.

The recalled units are identified by UDI 00841436107327 and multiple lot numbers ranging from A018067 through A041723. The source document does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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 Quantity: 107 units 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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