Recall Z-0099-2015 ยท FRN Pump, Infusion
Intra Pump Infusion Systems
CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle"
| Date | Oct 21, 2014 (initiated Oct 18, 2013) |
| Status | Terminated |
| Reason | Product has the potential to have a clear debris on the tip of the needle. |
| Root cause | Device Design |
| Action | Cane S.p.A. Medical Technology sent an Urgent: Correction and Removal Action Required letter dated October 21, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken: a. Stop using the 19G x 11/2" 1.10 x 40mm steelneedle included in the CRONO Syringe blister pack. B. Safely discard the 19G x 11/2" 1.10 x 40mm steel needle into a Sharps container. c. Use a TRANSFER DEVICE (e.g.,Needleless adapter with female-to-female luer connector) or alternative device to transfer medications into the CRONO syri |
| Quantity | 25,440 pieces |
| Distribution | Worldwide Distribution: US (nationwide) in states of CA, PA, MA, IL, OH and NY; and Internationally to Canada. |
| FDA record | Open on fda.gov |