FDAOctober 16, 2015device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Utah Medical is conducting a recall of Myelo-Nate CSF Sampling Kit due to an internal post-sterilization inspection that found a sterile finished tray where the seal between the Tyvek lid and the PETG tray on one side of the tray had been compromised.

What to do

FDA enforcement status: Terminated

Brands named

utah medical productsutahutah medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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