Medline Head and Neck Kits Recalled for Contaminated Component
Medline is recalling 24 convenience kits labeled as MAJOR HEAD AND NECK PPS because they contain a potentially contaminated component.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a potentially contaminated component in a medical device, which poses a risk of harm, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling 24 convenience kits labeled as MAJOR HEAD AND NECK PPS (SKU DYNJ9425991S). The recall was initiated because the kits contain a potentially contaminated component.
The affected products were distributed nationwide in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, and WI. The specific lot number is 25LLA853, and the UDI/DI is 10198459312557 (each) and 40198459312558 (case).
Consumers should check their inventory for this specific SKU and lot number. If found, they should stop using the product and contact Medline Industries, LP for further instructions.
The recalled product
- Product
- Medline convenience kits labeled as: MAJOR HEAD AND NECK PPS, Medline Kit SKU DYNJ9425991S
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 24
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 (2)
- UDI/DI 10198459312557 (each) 40198459312558 (case)
- Lot Number 25LLA853
Distribution
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