Presource Fistulogram Pack, Cat. SANOCFGHHA, Hartford Hospital, Sterile.
Summary
The FDA issued a Class II for Presource Fistulogram Pack, Cat. SANOCFGHHA, Hartford Hospital, Sterile. by Cardinal Health 200, LLC. Reason: Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits)..
Details
Source
Device Recall
External ID
Z-0092-2024
Action Date
2023-10-18
Status
Ongoing
Category
device
Product Description
Presource Fistulogram Pack, Cat. SANOCFGHHA, Hartford Hospital, Sterile.
Lot/Code Info: Lot #23520, Exp. 2/1/2025, UDI-DI 10888439920840.
Quantity Affected: 13,351 total packs
Reason for Recall
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
Distribution
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WV. There was government distribution and no military distribution. The country of Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-16
Company
Waukegan, IL
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 179 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Cardinal Health 200, LLC has 153 FDA actions in our database, including 152 recalls and 1 clearance.
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 (Cardinal Health 200, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cardinal Health 200, LLC have FDA actions?
Cardinal Health 200, LLC has 153 FDA actions in our database, including 152 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0092-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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