Recall Z-0233-2016— Utah Medical Products, Inc
Class II · Terminated
Class II FDA medical device recall by Utah Medical Products, Inc, initiated 2015-10-16, terminated 2016-05-02. It names one FDA 510(k) clearance: K821814. 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: 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..
- Recalling firm
- Utah Medical Products, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-10-16
- Terminated
- 2016-05-02
- Firm location
- Midvale, UT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.