abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF BC21087 abm Respiratory Care Standart Bre
Summary
The FDA issued a Class III for abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF BC21 by S & MOHR AMERICA, S.A. DE C.V.. Reason: Incorrect expiration date on product label. The manufacturing date was listed as the expiration date. Correct expiration date is "22.07.2027".
Details
Source
Device Recall
External ID
Z-1160-2023
Action Date
2023-03-01
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: 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
Quantity Affected: 1,320 masks
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"
Distribution
U.S. Nationwide distribution in the state of MN.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-01-05
Company
Estado De Mexico, N/A
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 136 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (S & MOHR AMERICA, S.A. DE C.V.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does S & MOHR AMERICA, S.A. DE C.V. have FDA actions?
This is the only FDA action we have on record for S & MOHR AMERICA, S.A. DE C.V. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1160-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29