Z-0233-2016Class II

Myelo-Nate CSF Sampling Kit, Neonatal/Pediatric cerebralspinal fluid sampling sterile tray, including a...

Name: Z-0233-2016 Myelo-Nate CSF Sampling Kit, Neonatal/Pediatric cerebralspinal fluid sampling sterile tray, including a...
Creator: Utah Medical Products, Inc
Published: 2015-10-16
License: https://open.fda.gov/license/

Utah Medical Products, Inc / initiated 2015-10-16 / Terminated / root cause: packaging

FDA source

Utah Medical Products, Inc began a recall of Myelo-Nate CSF Sampling Kit, Neonatal/Pediatric cerebralspinal fluid sampling sterile tray, including a lumbar puncture needle, four collection vials, an... on 2015-10-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0233-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-16
Posted: 2015-11-06
Terminated: 2016-05-02
Recalling firm: Utah Medical Products, Inc
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.
Product code: KDD Kit, Surgical Instrument, Disposable
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.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Consignees notified on 10/15/15 via letter and email, instructed to return product to distributor.
Quantity in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0233-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0233-2016	Class II	Terminated	N/A	2015-11-18	2015-11-06

Product code KDD

K821814Class IHemo-Nate L-P KitInt'L Corp. / cleared 1982-07-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)