FDA-Device2025-10-08Class I
Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B
Hazard
Convenience kits labeled as sterile have not gone through the sterilization process.
Sold states
US Distribution to States of: FL, MD, NJ, TN
Affected count
88 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2593-2025More Medline Industries, LP recalls
- FDA-Device2026-07-22Medline Total Knee Pack surgical kits recalled for sterility seal defects
- FDA-Device2026-07-22Medline Total Knee Pack recalled for seal defects risking sterility breach
- FDA-Device2026-07-08Medline Convenience kits recalled for defective Swan-Ganz catheters with leak and breakage risk
- FDA-Device2026-07-08Medline Convenience kits recalled for defective Swan-Ganz catheters with leak risk
- FDA-Device2026-07-08Medline surgical and procedure kits recalled for lidocaine ampule quality issues
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