Medline sterile convenience kits recalled for lacking sterilization
Medline Industries recalls 88 Extremity Pack convenience kits that were labeled as sterile but did not undergo sterilization. The affected units were distributed to healthcare facilities in Florida, Maryland, New Jersey, and Tennessee.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I medical device recall. Although no illnesses or injuries have been reported, the sterilization failure of surgical kits creates a reasonable probability of serious infection risk, which is the defining characteristic of Class I classification.
Plain-English summary
Medline Industries, LP is recalling sterile Convenience Kits (Extremity Pack, Model DYNJ45701B) due to a critical sterilization failure. The recalled kits were labeled and marketed as sterile but did not undergo the required sterilization process.
Convenience kits that are not properly sterilized present a significant infection risk when used in medical procedures. Because these products are intended for clinical use, any contamination could lead to serious infections or other adverse health consequences for patients.
The recall affects 88 units distributed to healthcare facilities in the United States across Florida, Maryland, New Jersey, and Tennessee. Affected kits carry lot number 25GBF686 and model number DYNJ45701B.
Healthcare facilities that received these kits should quarantine them immediately and not use them for any medical procedures. Facilities should contact Medline Industries for instructions on return or disposal of the affected product.
The recalled product
- Product
- Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kit
- Hazard
- sterility-failure
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 1) DYNJ45701B
- UDI-DI: 10193489856279(each)
- 40193489856270(case)
- Lot Number: 25GBF686
Distribution
Distributed in 4 states:
- FL
- MD
- NJ
- TN
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