Recall Z-0233-2016 ยท KDD Kit, Surgical Instrument, Disposable
Utah Medical Products, Inc
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.
| Date | Nov 6, 2015 (initiated Oct 16, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Package design/selection |
| Action | Consignees notified on 10/15/15 via letter and email, instructed to return product to distributor. |
| 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, Kuwa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K821814 | HEMO-NATE L-P KIT Int'L Corp., Jul 9, 1982 |