Utah Medical Products, Inc: Medical Device Recall in 2015 - (Recall #: Z-0233-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 16, 2015

Date Posted: November 18, 2015

Recall Number: Z-0233-2016

Event ID: 72462

Reason for Recall:

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.

Status: Terminated

Product Quantity: 21,403 trays

Code Information:

Part numbers: 4011015 (22 ga X 1.0 long needle) 4011525 (22 ga X 1.5 long needle) 4011515 (25 ga X 1.0 long needle) Expiration dates from 10/31/15 to 12/31/17.

Distribution Pattern:

Worldwide Distribution-US (nationwide) including Puerto Rico and the states of CA, CO, MD, WI, FL, GA, IL, IA, ID, IN, KS, KY, LA, MI, MN, MO, MS, NC, NE, NJ, NV, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WI, and the countries of Canada, United Kingdom, Saudi Arabia, Jordan, United Arab Emirates, Kuwait, and Costa Rica.

Voluntary or Mandated:

N/A