Myelo-Nate CSF Sampling Kit — Class II medical device recall Z-0233-2016
Terminated recall by Utah Medical Products, Inc, reported 2015-11-18, distributed nationwide. Utah Medical is conducting a recall of Myelo-Nate CSF Sampling Kit due to an internal post-sterilization inspe
| Recall number | Z-0233-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Recalling firm | Utah Medical Products, Inc, Midvale, UT, United States |
| Recall initiated | 2015-10-16 |
| Classified | 2015-11-06 |
| Reported by FDA | 2015-11-18 |
| Terminated | 2016-05-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, CR, GB, JO, KW, SA |
| Quantity | 21,403 trays |
| Reason classes | sterility, packaging |
| Model numbers | 4011015 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0233-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.