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Z-0233-2016 Class II Terminated

Recalled by Utah Medical Products, Inc — Midvale, UT

FDA device recall Z-0233-2016 was initiated by Utah Medical Products, Inc on October 16, 2015 and is designated Class II. 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 PET… The recall status is terminated (terminated May 2, 2016). Affected quantity: 21,403 trays.

Recall Details

Product Type: Devices
Report Date: November 18, 2015
Initiation Date: October 16, 2015
Termination Date: May 2, 2016
Voluntary/Mandated: N/A
Product Quantity: 21,403 trays

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.

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.

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.