Z-0053-2020Class II

Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF...

Name: Z-0053-2020 Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF...
Creator: Arrow International Inc
Published: 2019-05-17
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2019-05-17 / Terminated / root cause: manufacturing process

FDA source

Arrow International Inc began a recall of Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502 Product Usage; Provide short-term (< 30 days)... on 2019-05-17. FDA classified it as Class II and gives the reason as "Lidstock contains a labeling error. The lidstock shows the catheter cross section of the gauge (GA) values in a reversed manner". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0053-2020
Classification: Class II
Status: Terminated
Initiated: 2019-05-17
Posted: 2019-10-07
Terminated: 2020-09-24
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502 Product Usage; Provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: Lidstock contains a labeling error. The lidstock shows the catheter cross section of the gauge (GA) values in a reversed manner.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On May 17, 2019, Arrow International issued Urgent Medical Device and Acknowledgement notices to customers via courier service. Customers should take the following actions: 1. Place a copy of the notification with each unit of affected product currently in your inventory. 2. After step (1) is complete, fill out the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to [email protected]. Distributors should take the following actions: 1. Place a copy of the notification with each unit of affected product currently in your inventory. 2. Using the provided customer letter template and acknowledgement form, communicate the notification to any of your customers who have received product included within the scope of the 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 the 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: 3,143
Distribution: US Nationwide Distribution
Product codes and lots: Lot/Batch Numbers: 13F18C0374, 13F18H0580, 13F18D0504, 13F18L0507, 13F18E0380, 13F18L0714, 13F18G0180, 13F18L0936, 13F18G0480

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0053-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0053-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-07

Product code FOZ

K900263Class IIAntimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. / cleared 1990-07-24

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)