Z-0723-2019Class II

Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2...

Name: Z-0723-2019 Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2...
Creator: Arrow International Inc
Published: 2018-11-14
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2018-11-14 / Terminated / root cause: labeling and UDI

FDA source

Arrow International Inc began a recall of Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm, Reference # CS-12402 The Arrow CVC is... on 2018-11-14. FDA classified it as Class II and gives the reason as "The lidstock states the incorrect priming volume and flow rates". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0723-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-14
Posted: 2019-01-11
Terminated: 2020-06-04
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm, Reference # CS-12402 The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access, including, but not limited to the following: " Lack of usable peripheral IV sites " Central venous pressure monitoring " Total parenteral nutrition (TPN) " Infusions of fluids, medications, or chemotherapy " Frequent blood sampling or receiving blood transfusions/blood products
Product code: DQY Catheter, Percutaneous
Reason for recall: The lidstock states the incorrect priming volume and flow rates.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: The firm, Teleflex, sent an "Urgent Medical Device Notification" letter dated 11/13/2018 to its customers on 11/14/2018. The letter described the product, problem and action to be taken. The customers were instructed to do the following: 1. Place a copy of this notification with each unit of affected product currently in your inventory. 2. Using the provided customer letter template and acknowledgement form, communicate this notification to any of your customer who have received product included within the scope of this notification. 3. Have each of your customers who received the affected product return a completed acknowledgement form to you. 4. Once you have finished collecting and consolidating all of the acknowledgement forms from your customers and placing a copy of this notification with each unit of affected product in your inventory, please completed the enclosed Distributor Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to [email protected]. This will allow us to document completion of this field action. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.
Quantity in commerce: 15 in the US
Distribution: Worldwide distribution: US (nationwide) distribution to state of: FL and to countries of: Argentina, Canada, Chile, Columbia, Costa Rica, Dominican Republic, Ecuador, and Peru.
Product codes and lots: Lots 14F18F0336 & 14F18E0121

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0723-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0723-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-23	2019-01-11

Product code DQY

K862056Class II[Central Venous][multi-Lumen] Catheter W/flex TipArrow Intl., Inc. / cleared 1986-08-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)