| Class 2 Device Recall Mucolexx / Mucolytic Agent | |
Date Initiated by Firm | April 29, 2015 |
Date Posted | May 21, 2015 |
Recall Status1 |
Terminated 3 on March 09, 2016 |
Recall Number | Z-1639-2015 |
Recall Event ID |
71178 |
Product Classification |
Preservative, cytological - Product Code LEA
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Product | Mucolytic Agent 1 pint/473 ml; 1 gallon/3.8 l
Product Usage:
A mucoliquefying preservative designed for use in the preparation of mucoid cytology specimens. Mucolexx & Mucolytic Agent liquefies mucus and allows for optimal cytologic diagnostic results. |
Code Information |
Richard Allan Scientific Mucolytic Agent 1 pint / 473 ml Product code: 76166, Lot #s and EXP Dates: 313839-Dec 2016; 311157-Oct-2016; 306726-Aug-2016; 297142-Jun-2016; 296289-May-2016; 290486-Mar-2016; 289488-Mar-2016; 276824-Nov-2015; 271110-Oct-2015; 265368-Aug-2015. Richard Allan Scientific Mucolytic Agent 1 gallon/ 3.8 l, Product Code: 76167; Lot Number & EXP Dates: 311158- Oct-2016; 302099- Jun-2016; 298834-Jun-2016; 293734- Apr-2016; 288009-Feb-2016; 283396-Jan-2016; 279581-Nov-2015; and 274814- Oct-2015 Dec-2016 Oct-2016 Aug-2016 Jun-2016 May-2016 Mar-2016 Mar-2016 Nov-2015 Oct-2015 Aug-2015 |
Recalling Firm/ Manufacturer |
Richard-Allan Scientific Company 4481 Campus Dr Kalamazoo MI 49008-2590
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For Additional Information Contact | Sarah Rickert 616-544-5628 |
Manufacturer Reason for Recall | Richard Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx following a customer complaint reporting that a lab had found fungal contamination in 2 lots of Mucolexx. |
FDA Determined Cause 2 | Material/Component Contamination |
Action | Richard Allan Scientific (RAS) initiated a voluntary recall of Mucolexx and Mucolytic Agent due to fungal contamination on 5/1/2015 via certified mail to all customers who received the affected. Customers were asked to return a repsonse form, and dispose or return all recalled products. Please contact Sarah Rickert at 269-544-5628 or sarah.rickert@thermofisher |
Quantity in Commerce | Product 76166- 116; Product Code 76167-29 |
Distribution | Worldwide Distribution - US Nationwide in the states of: AR; AZ; CA; CO; FL; GA; I A; IL; IN; KY; MA; MN; MO; MS; MT; NC; ND; NJ; NV; NY; OH; OK; PA; PR; SD; TN; TX; VA; WA; WI and the countries of: Bangladesh, Canada, China, Costa Rica, Dubai, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Korea, Netherlands, Panama, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, and UK. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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