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Recall Observatory FDA recall evidence

Device 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.

Z-0233-2016

October 16, 2015

Class II

Product summary

Firm
Utah Medical Products, Inc
Event
Event 72462
Status
Terminated
Classification
Class II
Quantity
21,403 trays
Official record key
device-enforcement:Z-0233-2016

Official wording

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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.