FDA identifies recall of catheter kits, early alert for sterile labels
The Food and Drug Administration notified the public that Arrow International recommends dialysis catheter kits containing Merit Medical 16F Dual-Valved Splittable Sheath Introducers be taken out of use due to a design defect where the sheath introducer may not split as intended. In addition, the FDA issued an early alert for Omnicell i.v.STATION sterile labels. Omnicell recommends customers do not use affected labels. They should verify the accuracy of labels on filled products.