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

FDA device recall Z-0099-2015 · posted 2014-10-21 · Terminated

Recall details

Recalling firm

Intra Pump Infusion Systems

Reason for recall

Product has the potential to have a clear debris on the tip of the needle.

Action taken

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

Status

Terminated

Product code

FRN

Quantity affected

25,440 pieces

Distribution

Worldwide Distribution: US (nationwide) in states of CA, PA, MA, IL, OH and NY; and Internationally to Canada.

Date initiated

2013-10-18

Date posted

2014-10-21

Date terminated

2016-02-01

Location

Grapevine, TX

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