Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DRAPE PACK, REF DYNJ44114; b) DRAPE PACK
Summary
The FDA issued a Class II for Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DR by MEDLINE INDUSTRIES, LP - Northfield. Reason: It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-steri.
Details
Source
Device Recall
External ID
Z-0171-2025
Action Date
2024-10-30
Status
Ongoing
Category
device
Product Description
Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DRAPE PACK, REF DYNJ44114; b) DRAPE PACK, REF DYNJ82663B
Lot/Code Info: a) REF DYNJ44114, UDI/DI 40888277202055 (each), 10888277202054 (case), Lot Numbers: 24ABB398; b) REF DYNJ82663B, UDI/DI 40195327544325 (each), 10195327544324 (case), Lot Numbers: 23LBV498
Quantity Affected: 194 units
Reason for Recall
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-04
Company
Northfield, 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 253 device recalls issued in the same week, part of 413 device-related FDA actions this month.
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 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 - Northfield) 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 - Northfield have FDA actions?
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0171-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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