Medline Medical Convenience Kits Recalled for Endotoxin Levels
Medline Industries is recalling 2,262 medical convenience kits containing neurosponges due to potential out-of-specification endotoxin levels.
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 is classified as FDA Class II, and the hazard involves endotoxin contamination in medical devices. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
Medline Industries, LP is recalling 2,262 medical convenience kits, including various ENT, sinus, and head & neck packs, due to potential out-of-specification levels of endotoxin in the Pilling Wecksorb Neurosponges and Neurosponge Strips contained within the kits.
The affected kits were distributed nationwide in the states of Arizona, California, Iowa, Idaho, Illinois, Indiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, New York, Ohio, Texas, Wisconsin, and Wyoming. Specific lot numbers and UDI/DI codes for the affected SKUs are listed in the official recall notice.
Healthcare facilities and consumers should stop using the affected kits and contact Medline Industries for further instructions or a replacement.
The recalled product
- Product
- Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F; 2) ENT PACK, Medline Kit SKU DYNJ40154D; 3) ENT PACK, Medline Kit SKU DYNJ40154F; 4) ENT SCOPE PACK, Medline Kit SKU DYNJ44480D; 5) ENT NASAL ORAL PACK MOSES, Medline Kit SKU…
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 2,262
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 (20)
- Medline Kit SKU DYNJ0966146F
- UDI/DI 10193489916379 (each) 40193489916370 (case)
- Lot Number 23HBC070
- Medline Kit SKU DYNJ40154D
- UDI/DI 10889942968732 (each) 40889942968733 (case)
- Lot Number 24CBA416
- Lot Number 23CBS214
- Lot Number 23FBC803
- Lot Number 23GBU042
- Lot Number 23IBO417
- Medline Kit SKU DYNJ40154F
- UDI/DI 10195327679293 (each) 40195327679294 (case)
- Lot Number 24EBH594
- Lot Number 24FBQ494
- Lot Number 24JBK316
- Medline Kit SKU DYNJ44480D
- UDI/DI 10198459241727 (each) 40198459241728 (case)
- Lot Number 25CDA135
- Medline Kit SKU DYNJ58928A
- UDI/DI 10193489763973 (each) 40193489763974 (case)
Distribution
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