Medline neuro procedure kits recalled for dimensional fitting variation
Medline is recalling 2,013 medical procedure kits due to a slight dimensional variation that may cause difficulty fitting into the outer canister. No injuries reported.
What this means for you
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: This is a Class II FDA medical device recall for a functional defect (dimensional variation affecting proper fitting) in procedure kits. While no injuries have been reported and the hazard is theoretical, the risk-of-harm nature of a medical device with a dimensional defect meets the High severity criterion.
Plain-English summary
Medline Industries is recalling 2,013 units of medical procedure kits across multiple product lines (Basic Neuro, Neuro, and Neuro SAS) due to a slight dimensional variation. This variation has the potential to cause increased difficulty when fitting the kits into the outer canister.
The affected kits have been distributed worldwide, including throughout the United States and to Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, and Singapore. Specific lot numbers and reference codes for each product variant are available from the FDA.
Healthcare facilities and medical professionals in possession of these kits should stop using the affected batches and contact Medline Industries for instructions regarding product replacement or return. No injuries or illnesses related to this dimensional variation have been reported.
The recalled product
- Product
- Medline medical procedure kits labeled as follows: a) BASIC NEURO, REF DYNJ909171A; b) NEURO, REF DYNJ905510D; c) NEURO, REF DYNJ902388L; d) NEURO SAS, REF DYNJ908566
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- fitting-difficulty
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)
- a) REF DYNJ909171A
- UDI/DI 40195327384570 (case)
- 10195327384579 (unit)
- Lot Numbers: 23ELA235
- 23ELA709
- 23FLA843
- 23FLB029
- 23ILA269
- 23JLA515
- 23KLA152
- b) REF DYNJ905510D
- UDI/DI 40193489967495 (case)
- 10193489967494 (unit)
- Lot Numbers: 22FMD495
- 22FME413
- 22JMG896
- 23CMA506
- 23DMF104
- 23DMG416
- 23DMH216
Distribution
Distributed nationwide across the United States.
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