Moldex produces disposable respirators with exhale valves that contain a natural rubber diaphragm. These products are very reliable but the shelf life can be affected by storage conditions such as heat and exposure to air and light. During a recent internal audit of retained products, we found that a limited number of exhale valves used in certain respirator models showed signs of hardening of the valve diaphragm. This condition may lead to reduced life of the valve and possible reduction in performance below the NIOSH standard. This was found in a few manufactured lots that were 5 years or more past their date of manufacture.
Moldex has changed its shelf life policy to 4 years for these type products even though they are almost always sold and used in a time period less than four years.
Effective 4/8/2015, all models of Moldex Disposable Respirators with exhalation valves will be standardized to carry a 4 year shelf life (herein referred to as expiration date). Most Moldex models with Exhale Valves already carry a 4 year expiration date. Therefore, standardization of the expiration date affects only those models that have previously carried an expiration date greater than 4 years.
Pursuant to this change in policy, Users must be advised to discontinue use of product that is more than 4 years past the date of manufacture. All Resellers must stop selling any product that is more than 3 years past date of manufacture. This applies only to products manufactured prior to April 8, 2012 (lot numbers 120407‐999 and lower).
Moldex will replace “Reseller Qualifying” returned product to you or your customer at no charge. Products that are less than 4 years from date of manufacture and already in possession of the User can be used for 4 years from the manufacture date and do not require recall nor removal from service.
Please refer to the Reseller Voluntary/Recall Notice below dated 4/14/2015 for “Reseller Qualifying” model numbers and detailed instructions to be taken on your part and to the Moldex User Voluntary/ Stop Use/ Relabel Expiration Date Notice dated 4/14/2015 regarding communications with your Users.
RESELLER VOLUNTARY RECALL/STOP SALE AND USE NOTICE/ RELABEL SHELF LIFE NOTICE
For Certain Moldex Model Numbers Produced before 4/8/2015
Series: 2300 N95, 2700 N95, EZ23N95 and EZ23S N95
NIOSH: 2236, 2300N95, 2300V, 2301N95, 2307N95, 2350N95, 2357N95, 2700N95, 2700V, 2701N95, 2707N95, M2700N95, M2701N95, M2707N95, EZ23, EZ23S
As part of Moldex’s commitment to producing safe, quality and innovative products, we constantly monitor them to ensure the health and safety of our customers. During a recent internal audit of retained products, we found that a limited number of exhale valves used in the above respirator models showed signs of hardening of the diaphragm valve on some lots that were 5 years or more past their date of manufacture. This condition may lead to reduced life of the valve and possible reduction in performance below the NIOSH standard.
While not all masks exhibited hardening of the diaphragm valve, in an abundance of caution, we have decided to implement a voluntary recall and stop sale of the above Moldex products that are older than the April 8, 2012 manufacturing date as marked on the product packaging. Users must be notified not to use product that is more than 4 years past the manufacturing date.
PRODUCTS SUBJECT TO THIS NOTICE are those Moldex models listed herein that were produced prior to April 8, 2015. These products have manufacturing lot numbers 150407‐999 or lower and under the context of this notice are considered “Reseller Qualified” products. Based upon the date of manufacture, “Reseller Qualified” products are subject to a stop sale. Product 3 years or less from April 8, 2012 manufacture date must be relabeled by the reseller to correct shelf life expiration marking or returned to Moldex for relabeling. Product more than 3 years older than April 8, 2012 manufacture date must be returned to Moldex for replacement. Further guidance is provided in the next section.
Important note: the above models with manufacturing lot number of 150408‐000 and higher will already be marked with a 4 year expiration date and are therefore not affected by this Voluntary Recall/Stop Sale Notice.
Please immediately do the following:
For Product in Your Inventory:
1. Lot #’s 150407‐999 and below
Date of manufacture: 4/7/2015 and earlier
A. Action – See attachment 1 and 2 for lot number location.
B. Stop sale of above lot numbers
C. Provide Moldex with Model numbers, lot numbers and quantities
D. Proceed to steps 2 and 3 below
2. Lot#’s 120408‐000 to 150407‐999
Date of manufacture: 4/7/2012 – 4/8/2015
A. Action –Relabel product to reduce expiration year by 5 years (e.g. 2024 becomes 2019; 2023 becomes 2018 etc.). See Attachments 1 and 2 for interpretation of manufacturing lot number date.(Moldex will send preprinted year labels)
3. Lot #’s lower than 120408‐000
Date of manufacture: 4/8/2012 and before
A. Action – obtain return authorization from Moldex
B. Return product to Moldex for replacement as instructed
For Products at your resellers and users:
1. Compile a list of your customers who have purchased affected product and contact them directly or provide Moldex with that list.
2. If you will be contacting your customers directly, send notice to your Resellers and Users
3. Determine if you will be taking product back on behalf of your customers. If so, once product is in your, possession obtain an RA number from Moldex Customer Service at 800‐421‐0668 ext. 550
4. If customer is sending product back themselves, tell them to contact Moldex Customer Service at 800‐421‐0668 ext. 550to obtain an RA number.
Note: this voluntary recall/stop sale does not apply to any other Moldex Disposable Mask Models not listed on this recall notice
Please contact Moldex Customer Service at 800‐421‐0668 ext. 550 or TECH@moldex.com if you have questions or to arrange the return of the affected Moldex models.