Utah Medical Recalls Myelo-Nate CSF Sampling Kits Due to Seal Compromise
Utah Medical Products is recalling 21,403 Myelo-Nate CSF Sampling Kits because an internal inspection found a compromised sterile seal on one side of the tray.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score based on the potential for harm without confirmed adverse events.
Plain-English summary
Utah Medical Products, Inc. is conducting a recall of 21,403 units of the Myelo-Nate CSF Sampling Kit. This sterile tray is designed for neonatal and pediatric cerebrospinal fluid sampling and includes a lumbar puncture needle, collection vials, and other sterile supplies.
The recall was initiated after an internal post-sterilization inspection identified a sterile finished tray where the seal between the Tyvek lid and the PETG tray had been compromised on one side. This defect potentially affects the sterility of the contents.
The affected products were distributed nationwide in the United States, including Puerto Rico, as well as in Canada, the United Kingdom, Saudi Arabia, Jordan, the United Arab Emirates, Kuwait, and Costa Rica. The specific part numbers involved are 4011015, 4011525, and 4011515, with expiration dates ranging from October 31, 2015, to December 31, 2017. Users should stop using these kits and contact the manufacturer for further instructions.
The recalled product
- Product
- Myelo-Nate CSF Sampling Kit, Neonatal/Pediatric cerebralspinal fluid sampling sterile tray, including a lumbar puncture needle, four collection vials, an iodine swabstick package, a fenestrated drape, a polylined drape, three gauze pads, and one spot bandage.
- Manufacturer
- Utah Medical Products, Inc
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 21,403
Distribution
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