CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle"
FDA Recall Z-0099-2015 · Posted 2014-10-21
Recalling FirmIntra Pump Infusion Systems
Recall StatusTerminated
Product CodeFRN
Date Initiated2013-10-18
Date Terminated2016-02-01
Product Quantity25,440 pieces
Reason for Recall
Product has the potential to have a clear debris on the tip of the needle.
Firm 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 syringe.
d.For intravenous infusions,we are recommending that a filter also be used during infusions.
e. Complete the required 'Acknowledgment and Receipt Form'and fax back to our Distributor;Intra Pump Infusion Systems at 630-845-2768.
Contact Information for our US Distributor: INTRA PUMP INFUSION SYSTEMS " Monday through Friday 8:00am to 5:00pm CST,TollFree:1-866-
211-7867 " Direct:630-845-7867 " Fax:630-845-2768 www.lntrapump.com
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution: US (nationwide) in states of CA, PA, MA, IL, OH and NY; and Internationally to Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.