Z-2132-2016Class II

Item # 4042-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline, UPC...

Name: Z-2132-2016 Item # 4042-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline, UPC...
Creator: Lifeline First Aid LLC
Published: 2016-05-16
License: https://open.fda.gov/license/

Lifeline First Aid LLC / initiated 2016-05-16 / Terminated

FDA source

Lifeline First Aid LLC began a recall of Item # 4042-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline, UPC 845174004429 each; UPC 845174004436 master case of... on 2016-05-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2132-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-16
Posted: 2016-07-06
Terminated: 2017-02-22
Recalling firm: Lifeline First Aid LLC
Product: 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
Product code: CBP Valve, Non-Rebreathing
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.
FDA 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 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.
Quantity in commerce: 3572 units of item #4042; 29,088 units of item #4043; 1,248 units of item #4037
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2132-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2132-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-13	2016-07-06
Z-2133-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-13	2016-07-06

Product code CBP

K083418Class IICPR MaskFirstar Healthcare Co., Ltd. / cleared 2010-07-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)