Myelo-Nate CSF Sampling Kit recall
Myelo-Nate CSF Sampling Kit, Neonatal/Pediatric cerebralspinal fluid sampling sterile tray, including a lumbar puncture needle, four collection vials…
Why was Myelo-Nate CSF Sampling Kit recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Myelo-Nate CSF Sampling Kit, Neonatal/Pediatric cerebralspinal fluid sampling sterile tray, including a lumbar puncture needle, four collection vials…
- Recalling firm
- Utah Medical Products, Inc
- Quantity
- 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.
- Recall date
- November 18, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)