Class II — Utah Medical Products, Inc
| Recalling firm | UTAH MEDICAL PRODUCTS, INC. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 21,403 trays |
| Distribution | 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. |
| Initiated | 2015-10-16 |
| Classified | 2015-11-06 |
| Terminated | 2016-05-02 |
| Recall number | Z-0233-2016 |
| Initiation | N/A |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Utah Medical Products, Inc (Z-0233-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72462/
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