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U.S. Department of Health and Human Services

Class 3 Device Recall abm Respiratory Care Standart Breathing Circuit with Face Mask

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  Class 3 Device Recall abm Respiratory Care Standart Breathing Circuit with Face Mask see related information
Date Initiated by Firm January 05, 2023
Date Posted February 22, 2023
Recall Status1 Open3, Classified
Recall Number Z-1160-2023
Recall Event ID 91562
510(K)Number K192713  
Product Classification Filter, bacterial, breathing-circuit - Product Code CAH
Product abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF BC21087

abm Respiratory Care Standart Breathing Circuit with Face Mask - Child/Adult Small REF BC21088

abm Respiratory Care Standart Breathing Circuit with Face Mask - Adult Large REF BC21273

abm Respiratory Care Standart Breathing Circuit with Face Mask - Adult Medium REF BC21089
Code Information Product Code: BC21087 Lot Number: SM6002.2207.12 Product Code: BC21088 Lot Number: SM6003.2507.12 Product Code: BC21273 Lot Number: SM6001.2207.12 Product Code: BC21089 Lot Number: SM6004.2607.12
Recalling Firm/
Manufacturer		 S & MOHR AMERICA, S.A. DE C.V.
Circuito De La Industria Poniente Lote 10 C
Estado De Mexico Mexico
Manufacturer Reason
for Recall		 Incorrect expiration date on product label. The manufacturing date was listed as the expiration date. Correct expiration date is "22.07.2027"
FDA Determined
Cause 2		 Process control
Action On or about 01/10/2023, the firm emailed a Customer Notification to customers notifying them that specific lots of Breathing Circuits were incorrectly label with the manufacturing dated as the expiration date for the product. The correct expiration dates range from 07/22/2027 to 07/26/2027 (5 year shelf-life). Customers are informed that the affected products can be used without risk to the patient up and until July 2027. For questions, contact Quality Assurance Department at +905426624107 Monday through Friday between 8:00 a.m. to 5:00 p.m. EST
Quantity in Commerce 1,320 masks
Distribution U.S. Nationwide distribution in the state of MN.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = CAH and Original Applicant = Meditera Tibbi Malzeme San. ve Tic. A.S.
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