Z-2886-2018Class II

Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, Cat. No...

Name: Z-2886-2018 Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, Cat. No...
Creator: Arrow International Inc
Published: 2018-07-03
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2018-07-03 / 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, Cat. No. AK-22502 Product Usage: The multiple-lumen catheter... on 2018-07-03. FDA classified it as Class II and gives the reason as "One lot of product is from product code AK-22502 so it contains a 2-lumen, 5 Fr x 5 cm catheter. However, this product is incorrectly labeled as AK-25502, so the lidstock says it contains a 2-lumen, 5 Fr x 8 cm...". 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-2886-2018
Classification: Class II
Status: Terminated
Initiated: 2018-07-03
Posted: 2018-08-22
Terminated: 2020-04-29
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, Cat. No. AK-22502 Product Usage: The multiple-lumen catheter permits venous access to the central circulation of pediatric patients. The ARROWg+ard antimicrobial surface is intended to help provide protection against catheterrelated infections. The catheter is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use. The use of the 4, 5, and 5.5 Fr. antimicrobial surface catheters in infants weighing less than 2.0, 2.5, and 3.0 kilograms respectively, have not been evaluated. Therefore, the benefits of these catheters in infants weighing less than the indicated weights should be weighed against any possible risks.
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: One lot of product is from product code AK-22502 so it contains a 2-lumen, 5 Fr x 5 cm catheter. However, this product is incorrectly labeled as AK-25502, so the lidstock says it contains a 2-lumen, 5 Fr x 8 cm catheter. No patient injuries have been reported related to this issue.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On July 3, 2018, the firm sent out Urgent Medical Device Recall letters to customers. The letter communicated the labeling error. Affected consignees are instructed to take the following actions: 1. If you have affected stock, immediately discontinue use and quarantine any products with the product code and lot number listed above, so that the affected products can be returned to Arrow. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Arrow International. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. This will allow us to document your receipt of this letter.
Quantity in commerce: 166
Distribution: Distributors in MO and UT. Medical facilities in AL, CA, IL, MA, NH, NM, NY, TX, VA, and WI.
Product codes and lots: 13F17K0202

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2886-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2886-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-22

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)