FDA Medical Device Recalls (openFDA)
Intra Pump Infusion Systems: CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle"
- Recall number
- Z-0099-2015
- Recalling firm
- Intra Pump Infusion Systems
- Product
- CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle"
- Status
- Terminated
- Initiated
- 2013-10-18
- Posted
- 2014-10-21
- Terminated
- 2016-02-01
- 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 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
- 25,440 pieces
- Distribution
- Worldwide Distribution: US (nationwide) in states of CA, PA, MA, IL, OH and NY; and Internationally to Canada.
- Lot, serial or model codes
- Product Code CRN20, lot numbers 14N02, 15E01, 15A02
- 510(k) numbers
- ["K041414","K042085","K052217","K052218","K052219"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 3004839315
- Firm city
- Grapevine
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28