CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle" recallZ-0099-2015 · Intra Pump Infusion Systems · initiated Oct 18, 2013
Class II Terminated All recalls posted in October 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Intra Pump Infusion Systems or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product has the potential to have a clear debris on the tip of the needle.
FDA root cause category: Device Design
What the company is doing
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
Recall details
- Recall number
- Z-0099-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 18, 2013
- Posted by the FDA
- Oct 21, 2014
- Recalling firm
- Intra Pump Infusion Systems
- Quantity
- 25,440 pieces
- Product code
- FRN
- FDA submissions
- K041414, K042085, K052217, K052218, K052219
- Distribution
- Worldwide Distribution: US (nationwide) in states of CA, PA, MA, IL, OH and NY; and Internationally to Canada.
Product description
CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle"
Code information (models, lots, serial numbers)
Product Code CRN20, lot numbers 14N02, 15E01, 15A02
Other devices under the same FDA submission
1 device cleared under K041414, K042085, K052217, K052218, K052219 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Crono Super PIDCane' SPA · Pump, Infusion2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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