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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 Masksee related information
Date Initiated by FirmJanuary 05, 2023
Date PostedFebruary 22, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1160-2023
Recall Event ID 91562
510(K)NumberK192713 
Product Classification Filter, bacterial, breathing-circuit - Product Code CAH
Productabm 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
ActionOn 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 Commerce1,320 masks
DistributionU.S. Nationwide distribution in the state of MN.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CAH
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