Civco Needle Guide Recall Due to Missing or Inadequate Adhesive
Civco Medical Instruments is recalling 107 units of CIVCO Needle Guides because the assembly may lack sufficient adhesive to hold the cannula in place.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect (missing/inadequate adhesive) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Civco Medical Instruments Co. Inc. is recalling 107 units of CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO. The recall was initiated because the assembly of the needle guides was found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide.
The affected units were distributed in the United States, Austria, Belgium, Denmark, France, Germany, Poland, Spain, Switzerland, and the United Kingdom. The recall involves specific lot numbers and UDI 00841436107327.
Consumers and healthcare facilities should check their inventory for the affected lot numbers and stop using these products if they match the recalled items. Civco Medical Instruments Co. Inc. is the recalling firm responsible for this action.
The recalled product
- Product
- CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO
- Manufacturer
- Civco Medical Instruments Co. Inc.
- Category
- Medical Device — Needle Guide
- Affected units
- 107
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI 00841436107327
- Lot numbers: A018067
- A018067
- A021026
- A021226
- A022447
- A023876
- A025137
- A02560
- A025606
- A026609
- A026610
- A028159
- A028645
- A029293
- A029383
- A032036
- A033139
- A033153
- A035009
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Civco Medical Instruments Co. Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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