The following report was received via facsimile:
This letter serves to notify of a potential safety related noncompliance deviation in a basic component as defined in 10CFR Part 21. The noncompliance involves a batch of Carbozinc 11 SG Base that is not curing properly.
A customer notified Carboline of concerns regarding the cure of a particular batch of Carbozinc 11 SG. Our salesman was contacted by the customer and the salesman initiated a report to our Technical Service group. The internal report was opened and investigation began on Friday 9/19/2014. Analysis of the retain sample by our plant Quality Control was requested, the results show a slower than normal cure. Material was then sent into Saint Louis R&D for additional analysis. On Tuesday, September 23, 2014, the analytical evaluation was reviewed by the product chemist and the batch cure issues were confirmed.
The batch has been placed on hold and reports have been run to determine where the batch has shipped.
We are notifying customers to review their use and stock of Carbozinc 11 SG, to discontinue use of this batch, 14FN6228L and return any material with the batch number of 14FN6228L.
Please contact our Customer Service Department at 1-800-848-4645 to obtain a Returned Goods Authorization. We will credit your account for this material, if you need replacement material, Customer Service can make the necessary arrangements at that time.
Further work is being done to determine the cause of cure issues with this batch of Carbozinc 11 SG. At this time, we have confirmed that this material is not curing properly.
If you have any questions or need additional information please contact me.
Respectfully submitted,
Marikay Speckert - Corporate Quality Manager - Carboline Company
2150 Schuetz Road - Saint Louis, MO 63146 - 314-644-1000 Ext. 2456