Device product
Westmed DISPOSABLE RESPIRATORY PRODUCTS NON-REBREATHER MASK, REF 3228-e, RX Only, CE0482, (01)10709078008020 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
Z-0742-2021
Product summary
- Firm
- Westmed, Inc.
- Event
- Event 86903
- Status
- Terminated
- Classification
- Class II
- Quantity
- 37,300 units
- Official record key
device-enforcement:Z-0742-2021
Official wording
Reason: There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the mask adapter resulting in a possible delay in treatment.
Code information: Lot # 081120N42, 090220N29, 091020N88
Distribution pattern: Worldwide distribution - US Nationwide distribution including in the states of PA, OK, MO, CO, RI, IL, CA, TX, OH, MD, IL, MN, KS and the countries of Canada, Korea, United Kingdom
Derived failure modes
-
Unknown
There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the mask adapter resulting in a possible delay in treatment.