Medline convenience kits labeled as: a. MIDDLE EAR PACK-LF, Model DYNJ0689093V, b. EENT PACK, Model Number DYNJ62927 M
Summary
The FDA issued a Class II for Medline convenience kits labeled as: a. MIDDLE EAR PACK-LF, Model DYNJ0689093V, by MEDLINE INDUSTRIES, LP - SPT. Reason: Kits contain leaking bottles of isopropyl alcohol.
Details
Source
Device Recall
External ID
Z-1472-2022
Action Date
2022-08-03
Status
Ongoing
Category
device
Product Description
Medline convenience kits labeled as: a. MIDDLE EAR PACK-LF, Model DYNJ0689093V, b. EENT PACK, Model Number DYNJ62927 Model/Catalog Number: a. DYNJ0689093V, b. DYNJ62927
Lot/Code Info: Lot Code: a. Model Number DYNJ0689093V, Lot Codes: 22DMI666, 21LBI103, 21HBO705, 21JBP781, 21JBQ762, 21FBG532, 21FBG535, b. Model Number DYNJ62927, Lot Numbers: 22BBB412
Quantity Affected: 477 units
Reason for Recall
Kits contain leaking bottles of isopropyl alcohol
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-06
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 163 device recalls issued in the same week, part of 403 device-related FDA actions this month.
MEDLINE INDUSTRIES, LP - SPT has 8 FDA actions in our database, including 8 recalls.
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 (MEDLINE INDUSTRIES, LP - SPT) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MEDLINE INDUSTRIES, LP - SPT have FDA actions?
MEDLINE INDUSTRIES, LP - SPT has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1472-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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