Recall Z-2132-2016— Lifeline First Aid LLC

Name: FDA recall Z-2132-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-16

Class II · Terminated

Class II FDA medical device recall by Lifeline First Aid LLC, initiated 2016-05-16, terminated 2017-02-22. It names one FDA 510(k) clearance: K083418. 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. Reason: 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..

Recalling firm: Lifeline First Aid LLC
Classification: Class II
Status: Terminated
Initiated: 2016-05-16
Terminated: 2017-02-22
Firm location: Wilsonville, OR, United States

510(k) clearances named in this recall

1 on FDA's record

K083418 — CPR MASKFirstar Healthcare Co., Ltd.·cleared 2010-07-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.