Z-2132-2016 Class II Terminated
FDA device recall Z-2132-2016 was initiated by Lifeline First Aid LLC on May 16, 2016 and is designated Class II. Reason for recall: First aid kits or rescue kits are recalled because they contains the CPR Shield with One Way Valve and Barrier Filter (mask) and this mask is cleared only for prescription use and is not cleared for o… The recall status is terminated (terminated February 22, 2017). Affected quantity: 3572 units of item #4042; 29,088 units of item #4043; 1,248 units of item #4037.
Recall Details
- Product Type
- Devices
- Report Date
- July 13, 2016
- Initiation Date
- May 16, 2016
- Termination Date
- February 22, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3572 units of item #4042; 29,088 units of item #4043; 1,248 units of item #4037
Product Description
Item # 4042-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline, UPC 845174004429 each; UPC 845174004436 master case of 6. Item #4043-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline. UPC Red color kit: 845174005464; UPC Lime color kit: 845174005594; UPC Purple color: 845174005600; UPC of master case of 6 845174005471 (2 each color) Item # 4037, Outfitter First Aid Kit, CPR shield with one way valve & barrier filter, brand Lifeline, UPC 845174003453
Reason for Recall
First aid kits or rescue kits are recalled because they contains the CPR Shield with One Way Valve and Barrier Filter (mask) and this mask is cleared only for prescription use and is not cleared for over-the-counter (OTC) use.
Distribution Pattern
Distributed in AZ, CA, CO, FL, GA, IL, KY, MD, MN, MO, MT, NE, NJ, NY, OK, OR, PA, SC, TN, UT, VA, WA, WA, and WI. Also distributed in New Zealand.
Code Information
item #4042 and item #4043 have the expiration date: 11/30/2017. Item #4037 has the following lots and expiration dates: Lot # Expiration Date 101483; 3/15 101546; 6/15 101682; 7/15 101804; 1/16 101812; 1/16 102032; 5/16 102109; 5/16 102098; 5/17 102130; 5/16 102296; 10/16 102317; 10/16 102295; 10/16 102372; 1/17 102638; 1/17 102694; 8/17