Summary
The FDA issued a Class II for SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09 by Sam Medical Products. Reason: Due to partially assembled valved dressing that has a hole within it instead of the intended non-valved dressing in the package resulting in that the .
Details
Source
Device Recall
External ID
Z-0789-2022
Action Date
2022-03-23
Status
Terminated
Category
device
Product Description
SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
Lot/Code Info: Model Number: CS203-EN UDI Code: (01)10822045000190(10)Y060321-09(17)270601 (Case Carton) UDI Code: (01)10822045000193(10)Y060321-09(17)270601 (Each Pouch/Package) Lot Number: Y060321-09
Quantity Affected: 2,950 packages
Reason for Recall
Due to partially assembled valved dressing that has a hole within it instead of the intended non-valved dressing in the package resulting in that the dressing cannot be centered over the open chest wound and create an occlusive seal due to the hole being present.
Distribution
U.S.: AZ, CA, CO, FL, GA, MA, NY, OR, PA, Puerto Rico, RI, TX, VA, and WA O.U.S.: Canada
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-28
Company
Tualatin, OR
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 145 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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 (Sam Medical Products) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Sam Medical Products have FDA actions?
This is the only FDA action we have on record for Sam Medical Products in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0789-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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