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U.S. Department of Health and Human Services

Class 2 Device Recall MyeloNate CSF Sampling Kit

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 Class 2 Device Recall MyeloNate CSF Sampling Kitsee related information
Date Initiated by FirmOctober 16, 2015
Date PostedNovember 06, 2015
Recall Status1 Terminated 3 on May 02, 2016
Recall NumberZ-0233-2016
Recall Event ID 72462
510(K)NumberK821814 
Product Classification Kit, surgical instrument, disposable - Product Code KDD
ProductMyelo-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.
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.
Recalling Firm/
Manufacturer		 Utah Medical Products, Inc
7043 South 300 West
Midvale UT 84047
For Additional Information Contact
801-566-1200 Ext. 4039
Manufacturer 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.
FDA Determined
Cause 2		Package design/selection
ActionConsignees notified on 10/15/15 via letter and email, instructed to return product to distributor.
Quantity in Commerce21,403 trays
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KDD
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