Recall Z-2133-2016 ยท CBP Valve, Non-Rebreathing
Lifeline First Aid LLC
5195GM, Cadillac First Aid Kit, #23459698, brand General Motors. No UPC.
| Date | Jul 6, 2016 (initiated May 16, 2016) |
| Status | Terminated |
| Reason | Cadillac First Aid Kit is recalled because it 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. |
| Root cause | Other |
| Action | The firm sent the PRODUCT RECALL NOTICE- LIFELINE FIRST AID KITS WHICH INCLUDE CPR MASK letter, dated 5/11/2016, to their consignees. CPR shields will be replaced without charge and acceptable Lifeline First Aid kits will be re-worked and returned using our standard RGA process. In addition, the firm sent the PRODUCT RECALL NOTICE- CADILLAC FIRST AID KIT letter, dated May 31, 2016, to General Motors. General Motors will be sending out a dealership bulletin to inform their customers of this issue. Once confirmed, replacement masks will be sent to the requested dealerships and made availabl |
| Quantity | 2975 kits |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083418 | CPR MASK Firstar Healthcare Co., Ltd., Jul 22, 2010 |