Z-2336-2018Class II

Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E Product CVCs are...

Name: Z-2336-2018 Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E Product CVCs are...
Creator: Arrow International Inc
Published: 2018-05-11
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2018-05-11 / Terminated / root cause: manufacturing process

FDA source

Arrow International Inc began a recall of Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E Product CVCs are intended to permit venous access to the central... on 2018-05-11. FDA classified it as Class II and gives the reason as "The recalling firm has received complaints related to increased resistance encountered when introducing the CVC over the spring wire guide. This may lead to procedural delay, and there may be need of medical...". 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-2336-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-11
Posted: 2018-06-29
Terminated: 2020-04-20
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E Product CVCs are intended to permit venous access to the central circulation through a single puncture site by way of the femoral, jugular, or subclavian veins.
Product code: DQY Catheter, Percutaneous
Reason for recall: The recalling firm has received complaints related to increased resistance encountered when introducing the CVC over the spring wire guide. This may lead to procedural delay, and there may be need of medical intervention by exchanging the catheter for another CVC catheter.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On May 11, 2018, the firm sent an Urgent Medical Device Recall letter to affected customers via FedEx. Distributors were instructed to take the following actions: 1. Immediately discontinue distribution and quarantine any products with the product code and lot number listed above. 2. Using the provided customer letter and Recall Acknowledgement Form templates, communicate this recall to any of your customers who have received product included within the scope of the recall. 3. Have the customers return any affected product to you, together with a completed Recall Acknowledgement Form, for consolidation and return to Arrow International. In the event that an alternative approach is needed, contact Arrow International Customer Service for more information at 1-866-396-2111. 4. To return affected products from your inventory, 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 product to Arrow International. 5. Once you have completed returning all of the recalled products from your own inventory, and collecting and consolidating all of the recalled products from your customers, please check the box on the enclosed Recall Acknowledgment Form that indicates that you have completed the recall 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 the recall. 6. If you and your customers 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: 1200
Distribution: Distributor in FL. International distribution to Czech Republic, Dominican Republic, France, Greece, and Italy.
Product codes and lots: 71F18A0682

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2336-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2336-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-06-29

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