Z-2819-2018Class II

HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece...

Name: Z-2819-2018 HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece...
Creator: Arrow International Inc
Published: 2018-07-10
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2018-07-10 / Terminated / root cause: packaging

FDA source

Arrow International Inc began a recall of HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14703 The... on 2018-07-10. FDA classified it as Class II and gives the reason as "The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2819-2018
Classification: Class II
Status: Terminated
Initiated: 2018-07-10
Posted: 2018-08-14
Terminated: 2020-05-27
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14703 The central venous catheter permits venous access to the central circulation through an indwelling Arrow percutaneous sheath introducer.
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: The firm, Teleflex, sent an "Urgent Medical Device Recall Notification" letter dated 7/10/18 to customers. The letter included the following instructions: 1. If you have affected stock, immediately discontinue use and quarantine any products with the product codes and lot numbers 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. Distributors were instructed to do the following: 1. Immediately discontinue distribution and quarantine any products with the product codes and lot numbers 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 s
Quantity in commerce: 5507 units
Distribution: Worldwide Distribution: US (nationwide) to the following states of: AK, AL, CA, FL, HI, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NE, NY, OH, OR, PA, SC, SD, TX, WI, and WV; to countries of:: Finland, Germany, Hungary, Netherlands, South Africa, United Arab Emirates and the United Kingdom.
Product codes and lots: 14F15G0105, 14F15H0230, 14F15L0085, 14F16A0438, 14F16C0142, 14F16D0060, 14F16F0046, 14F16F0564

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2819-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2818-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-14
Z-2819-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-22	2018-08-14

Product code FOZ

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)