Z-0099-2015Class II

CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle"

Name: Z-0099-2015 CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle"
Creator: Intra Pump Infusion Systems
Published: 2013-10-18
License: https://open.fda.gov/license/

Intra Pump Infusion Systems / initiated 2013-10-18 / Terminated / root cause: design

FDA source

Intra Pump Infusion Systems began a recall of CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle" on 2013-10-18. FDA classified it as Class II and gives the reason as "Product has the potential to have a clear debris on the tip of the needle". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0099-2015
Classification: Class II
Status: Terminated
Initiated: 2013-10-18
Posted: 2014-10-21
Terminated: 2016-02-01
Recalling firm: Intra Pump Infusion Systems
Product: CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle"
Product code: FRN Pump, Infusion
Reason for recall: Product has the potential to have a clear debris on the tip of the needle.
Root cause tag: design
FDA 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 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
Quantity in commerce: 25,440 pieces
Distribution: Worldwide Distribution: US (nationwide) in states of CA, PA, MA, IL, OH and NY; and Internationally to Canada.
Product codes and lots: Product Code CRN20, lot numbers 14N02, 15E01, 15A02

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0099-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0099-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-29	2014-10-20

Product code FRN

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)