Reported Sep 5, 2018 · Terminated
CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO
Civco Medical Instruments Co. Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Civco Medical Instruments Co. Inc. · 102 1st St S · Kalona, IA · 52247-9589
Is this the product you have?
- CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO
- Lot codes and dates
- UDI 00841436107334
- Lot numbers
A035054A042207
- Amount recalled
- 3 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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