Medline Sterile Medical Device Convenience Kits Recalled for Missing Sterilization
Medline Industries is recalling two sterile convenience kit models because the products were not sterilized despite being labeled as sterile. The kits were distributed to 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. Per the rubric, FDA Class I recalls score at least 4 (Severe). No injuries or illnesses have been reported, but the sterilization failure creates an inherent risk of infection when these devices are used.
Plain-English summary
Medline Industries, LP is recalling two models of sterile medical device convenience kits: MAJOR PACK L-F (Model Number DYNJ0382730O, Lot 25GBC583) and LB BASIC CUSTOM PACK (Model Number DYNJ61038B, Lot 25GBF720). These kits were labeled as sterile but did not undergo sterilization processing.
The kits were distributed to Florida, Maryland, New Jersey, and Tennessee. A total of 22 units were affected.
Non-sterile medical device kits present a potential infection risk. Consumers and organizations that received these kits should stop using them and contact Medline Industries for instructions on safe disposal or replacement.
The recalled product
- Product
- Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Number: DYNJ61038B
- Manufacturer
- Medline Industries, LP
- Hazard
- non-sterile
- mis-labeling
- 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 (8)
- 1) DYNJ0382730O
- UDI-DI: 10198459117992(each)
- 40198459117993(case)
- Lot Number: 25GBC583
- 2) DYNJ61038B
- UDI-DI: 10195327596316(each)
- 40195327596317(case)
- Lot Number: 25GBF720
Distribution
Distributed in 4 states:
- FL
- MD
- NJ
- TN
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