5195GM, Cadillac First Aid Kit, #23459698, brand General Motors. No UPC.
FDA device recall Z-2133-2016 · posted 2016-07-06 · Terminated
Recall details
- Recalling firm
- Lifeline First Aid LLC
- Reason for recall
- 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.
- Action taken
- 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 available to be ordered (at no cost) as needed. Please complete and fax the attached Customer Response Form to Lifeline at (503)783-3721. Consignees with questions should call Lifeline First Aid, LLC at (503)783-3660.
- Root cause
- Other
- Status
- Terminated
- Product code
- CBP
- Quantity affected
- 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.
- Date initiated
- 2016-05-16
- Date posted
- 2016-07-06
- Date terminated
- 2017-02-22
- Location
- Wilsonville, OR
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CPR MASK (K083418) | Firstar Healthcare Co., Ltd. | 2010-07-22 |