FDA Medical devices recall ·
Medline brand medical procedure convenience kits… recall
- Recall number
- Z-0171-2025
- Date
- (initiated September 4, 2024)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 194 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DRAPE PACK, REF DYNJ44114; b) DRAPE PACK, REF DYNJ82663B
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
a) REF DYNJ44114, UDI/DI 40888277202055 (each), 10888277202054 (case), Lot Numbers: 24ABB398; b) REF DYNJ82663B, UDI/DI 40195327544325 (each), 10195327544324 (case), Lot Numbers: 23LBV498
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0171-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.