Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall Arrow Pressure Injectable Arrowgard Blue Plus ThreeLumen CVC Kit

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 1 Device Recall Arrow Pressure Injectable Arrowgard Blue Plus ThreeLumen CVC Kitsee related information
Date Initiated by FirmOctober 27, 2022
Date PostedDecember 10, 2022
Recall Status1 Completed
Recall NumberZ-0352-2023
Recall Event ID 91090
510(K)NumberK002507 K071538 
Product Classification Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
ProductPressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d) ASK-45703-NS, e) ASK-45703-PAU, f) ASK-45703-PCAM1, g) ASK-45703-PCCH2, h) ASK-45703-PN; catheter introducer
Code Information a) ASK-42703-NS: UDI/DI 10801902162905, Lot Numbers: 13F22B0495 b) ASK-42703-PCCH2: UDI/DI 10801902141030, Lot Numbers: 13F22C0862 c) ASK-42703-PUPM1: UDI/DI 10801902159592, Lot Numbers: 13F22B0021 d) ASK-45703-NS: UDI/DI 10801902162912, Lot Numbers: 13F22C0244 e) ASK-45703-PAU: UDI/DI 10801902159110, Lot Numbers: 13F22D0121 f) ASK-45703-PCAM1: UDI/DI 10801902203158, Lot Numbers: 13F22C0553 g) ASK-45703-PCCH2: UDI/DI 10801902141047, Lot Numbers: 13F22B0641 h) ASK-45703-PN: UDI/DI 10801902140675, Lot Numbers: 13F22C0350
Recalling Firm/
Manufacturer		 ARROW INTERNATIONAL Inc.
3015 Carrington Mill Blvd
Morrisville NC 27560-5437
For Additional Information ContactCustomer Service
866-396-2111
Manufacturer Reason
for Recall		There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit.
FDA Determined
Cause 2		Process control
ActionThe firm issued an "URGENT MEDICAL DEVICE RECALL" to its consignees on 10/27/2022 by FedEx 2-day mail. The notice explained the problem, the risk, and requested the following: "Action list number 1 Medical facilities 1. Immediately check your inventory for product within the scope of this recall. Users should cease use and distribution of affected product and immediately quarantine the affected product. 2. If you have affected product, complete the RECALL ACKNOWLEDGEMENT FORM, Contact Teleflex Customer Service to receive a return goods authorization (RGA) number. 3. Complete and return form even if you do not have affected product. 4. Teleflex (or your local dealer) will issue a credit note upon receipt of the returned affected product. Action list number 2 Distributors 1. Provide this recall notice to all customers who have received affected product. Each customer is then required to complete the Acknowledgement Form (Appendix 1) and return it to you. 2. Immediately check your inventory for affected product. Cease use and distribution of affected product and immediately quarantine the affected product. You may then return all product in scope. 3. Confirm to Teleflex that you have completed the field activity outlined in actions 1 and 2 of this Action List Number 2. Upon completion of your actions, please forward the completed Acknowledgement Form to Teleflex Customer Service at the contact details provided below. Important - Please ensure you only list lot numbers in scope of this recall notice when completing the Acknowledgement Form (Appendix 1). 4. If you have further distributed product outside of your country, please notify Teleflex Customer Service by return email to the email address provided below. Customer Service via Email: Recalls@teleflex.com, Customer Service Telephone: 1-866-396-2111, or FAX: 1-855-419-8507. Customer Service hours of operation are 8am-7pm EST.
Quantity in Commerce1275 units
DistributionUS Distributor in states of: FL, GA, KY, OH, PA and WV.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = FOZ
510(K)s with Product Code = FOZ
-
-