RETAIL LEVEL RECALL PRODUCT RECALLED BY BATTLE CREEK EQUIIPMENT

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1 RETAIL LEVEL RECALL 10/21/16 Dear Member, The purpose of this letter is to advise you that Battle Creek Equipment Company is voluntarily recalling certain model numbers of Thermophore Classic Moist Heat Pads with July 2012 through July 2014 dates of manufacture. Instructions are provided to help you identify the model numbers and lot codes involved in this recall. No other Thermophore models or lot codes are affected by this recall. This recall likely does NOT affect your current inventory because BCE last shipped these units in mid However, we request that you verify whether any of the model numbers and lot codes on the attached sheets are included in your current inventory. Note that the model numbers and lot codes are printed on the end of the packaging as shown on the attached sheets. PRODUCT RECALLED BY BATTLE CREEK EQUIIPMENT MUTUAL ITEM # PRODUCT LOT # THERMOPHORE HEAT PAD STD 14X27 THERMOPHORE HEAT PAD PET 4X17 THERMOPHORE HEAT PAD MED 14X14 See attachments See attachments See attachments With this recall, you are asked to: Check your product for the affected Lots. Stop dispensing and quarantine all impacted product. DO NOT RETURN AFFECTED PRODUCT TO MUTUAL DRUG Follow instructions on the attached sheets. Call Battle Creek Equip at for additional information Contact Brent Slaughter if you have additional questions.

2 October 1, 2016 URGENT: Medical Device Recall Thermophore Classic moist heat pads manufactured between July 2012 and July 2014 Dear Customer, The purpose of this letter is to advise you that Battle Creek Equipment Company is voluntarily recalling certain model numbers of Thermophore Classic Moist Heat Pads with July 2012 through July 2014 dates of manufacture. Instructions are provided to help you identify the model numbers and lot codes involved in this recall. No other Thermophore models or lot codes are affected by this recall. This recall likely does NOT affect your current inventory because BCE last shipped these units in mid However, we request that you verify whether any of the model numbers and lot codes on the attached sheets are included in your current inventory. Note that the model numbers and lot codes are printed on the end of the packaging as shown on the attached sheet. We are aware that the electrical cord for the affected Thermophore Classic units can, in some rare situations, fail prematurely when the user over-stresses the cord in a particular way that is warned against in the user manual and on the labels. If the electrical cord is over-stressed by wrapping the cord tightly around the pad or bent sharply during use, the cord may wear or potentially crack open at specific points shown in the image below. Consumers have reported sparking, smoke, fire and mild shock when the failure occurs. Out of an abundance of caution, BCE is voluntarily recalling these units. No serious injuries have been reported due to the failure mode associated with this recall. Consumers are being asked to stop using the affected heating pads immediately and discard the units. PO Box 629, 702 South Reed Road, Fremont, IN The Original Drug-Free Pain Relief Company since 1931!

3 The rates of occurrence associated with this failure mode are less than 0.06% or less than one unit for every 1,800 in use, and less than 0.03% or less than one for every 3,400 units used in accordance with the user manual and labels. Over a period of three years, we are aware of 337 total failures. No serious injuries have been reported and the likelihood of injury to the user or damage to property is extremely remote. However, since it is a failure of the electrical cord which could cause a brief spark in some situations, we would rather proactively address the situation. Product manufactured after July 2014 is not affected by this recall. The electrical cord associated with this failure mode was discontinued from manufacturing by mid Please follow the instructions below to support our efforts to address the issue with the heating pads that were manufactured with this cord. If you are a re-seller or distributor of the product: Verify that you have received this letter by ing Service@BattleCreekEquipment.com o Include the company name to whom the letter was addressed o A form for this is included on the next page Verify whether you have any of the recalled units in your inventory. o If you do have recalled units on hand, call and our customer service team will approve a Return Authorization and all recalled product will be replaced. o A form for ing a request is included on the next page If you have records showing to whom you sold the recalled products, please contact us if you would be willing to: o Share this information with BCE for the purpose of this recall o Send out recall information provided by BCE o Post information about this recall Please contact us at service@battlecreekequipment.com or at between 8am and 5pm Eastern Time, M-F. Thank you in advance for your support of our efforts to inform consumers about this potential product issue. Fax Authorized by: David Underhill - President

4 MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form Response is Requested Customer Information: Customer Contact Company Name Street Address Town, State, Zip Code Telephone IF you have inventory on hand, please fill in the RA request information. Our team will contact you with an RA# if the information provided includes recalled items found on the recall list. DO NOT return any product to Battle Creek Equipment without first contacting us for an RA#. Doing so may delay or inhibit our ability to provide replacement products. Recall Return Authorization Request for Thermophore Classic Moist Heat Pads Model number: Lot number: Qty Model number: Lot number: Qty Model number: Lot number: Qty Model number: Lot number: Qty I have read and understand the recall instructions provided in the letter. Yes No Send via to: Service@BattleCreekEquipment.com or by mail to: BCE Recall PO Box 629, Fremont, IN Thank you for your help in this matter!

5 Model Number and Lot Code number can be found on the end of the product box Models: 055, 255 and 095 F Standard Thermophore Classic Moist Heat Pad F Standard Thermophore Classic Plus Moist Heat Pad F Standard CSA Thermophore Classic Moist Heat Pad

6 Models: 077, 277 and 097 F Petite Thermophore Classic Moist Heat Pad F Petite Thermophore Classic Plus Moist Heat Pad F Petite CSA Thermophore Classic Moist Heat Pad

7 Models: 056, 256 and 096 F Medium Thermophore Classic Heat Pad F Medium Thermophore Classic Plus Moist Heat Pad F Medium CSA Thermophore Classic Moist Heat Pad