| Date Initiated by Firm | October 18, 2013 |
|---|
| Date Posted | October 21, 2014 |
|---|
| Recall Status1 |
Terminated 3 on February 01, 2016 |
| Recall Number | Z-0099-2015 |
|---|
| Recall Event ID |
66541 |
| 510(K)Number | K041414 K042085 K052217 K052218 K052219 |
|---|
| Product Classification |
Pump, infusion - Product Code FRN
|
| Product | CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle" |
|---|
| Code Information |
Product Code CRN20, lot numbers 14N02, 15E01, 15A02 |
| FEI Number |
3004839315
|
Recalling Firm/
Manufacturer |
Intra Pump Infusion Systems
920 Minters Chapel Rd Ste 200
Grapevine
TX
76051-1302
|
Manufacturer Reason
for Recall | Product has the potential to have a clear debris on the tip of the needle. |
|---|
FDA Determined
Cause 2 | 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. |
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| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
|
| 510(K) Database | 510(K)s with Product Code = FRN
|
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