Z-1005-2018Class II

ARROWg+ard BLUE PLUS Pressure Injectable Quad- Lumen CVC Kit

Name: Z-1005-2018 ARROWg+ard BLUE PLUS Pressure Injectable Quad- Lumen CVC Kit
Creator: Arrow International Inc
Published: 2017-11-27
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2017-11-27 / Terminated / root cause: labeling and UDI

FDA source

Arrow International Inc began a recall of ARROWg+ard BLUE PLUS Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow CVC is indicated to provide short-term (< 30 days) central venous access... on 2017-11-27. FDA classified it as Class II and gives the reason as "Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information". 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-1005-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-27
Posted: 2018-03-14
Terminated: 2020-09-22
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: ARROWg+ard BLUE PLUS Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: On November 29, 2017 an Urgent Medical Device Correction notice was issued to customers stating the following: Our records indicate that you have received products that are subject to this action. We are now notifying our distributors to take the following actions: 1. Immediately discontinue distribution and quarantine any products with the product codes and lot numbers listed above. 2. Inspect affected products within your control to identify whether they have the sticker with the lot number, expiration date, and UDI information. Products missing this sticker should be returned to Arrow International so they are not distributed to health care providers in error. Products which are properly labeled should not be returned. 3. Using the provided Customer Letter and Acknowledgement Form templates, communicate this correction to any of your customers who have received products included within the scope of the correction. Customers should return mislabeled products. Products that are properly labeled should not be returned. 4. If any of your customers have mislabeled products to return, have them return the affected products to you, together with a completed Acknowledgement Form, for consolidation and return to Arrow International. In the event that an alternative approach is needed, contact Customer Service for more information at 1-866-246-6990. 5. To return products to Arrow International, complete the enclosed 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 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. 6. If you and your customers have no affected stock or if the products in your stock are properly labeled, please complete the enclosed Acknowledgment Form and fax it to 1-855-419
Quantity in commerce: 23,904 in total
Distribution: US in the states of OH, FL, SC, TX, KY, NJ, MI
Product codes and lots: CDA-45854-P1A 13F17C0325 13F17D0283 13F17F0748

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1005-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0994-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13
Z-0995-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13
Z-0996-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13
Z-0997-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13
Z-0998-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13
Z-0999-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13
Z-1000-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13
Z-1001-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13
Z-1002-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13
Z-1003-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13
Z-1004-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13
Z-1005-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-13

Product code FOZ

K071538Class IIArrow, Arrowg+ard and Arrowg+ard Blue Plus Pressure Injectable Central Venous CatheterArrow International, Inc. / cleared 2007-08-30

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)