ARROW recallZ-0351-2023 · ARROW INTERNATIONAL Inc. · initiated Oct 27, 2022

Why it was recalled

There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit.

FDA root cause category: Process design

What the company is doing

The firm issued an "URGENT MEDICAL DEVICE RECALL" to its consignees on 10/27/2022 by FedEx 2-day mail. The notice explained the problem, the risk, and requested the following: "Action list number 1 Medical facilities 1. Immediately check your inventory for product within the scope of this recall. Users should cease use and distribution of affected product and immediately quarantine the affected product. 2. If you have affected product, complete the RECALL ACKNOWLEDGEMENT FORM, Contact Teleflex Customer Service to receive a return goods authorization (RGA) number. 3. Complete and return form even if you do not have affected product. 4. Teleflex (or your local dealer) will issue a credit note upon receipt of the returned affected product. Action list number 2 Distributors 1. Provide this recall notice to all customers who have received affected product. Each customer is then required to complete the Acknowledgement Form (Appendix 1) and return it to you. 2. Immediately check your inventory for affected product. Cease use and distribution of affected product and immediately quarantine the affected product. You may then return all product in scope. 3. Confirm to Teleflex that you have completed the field activity outlined in actions 1 and 2 of this Action List Number 2. Upon completion of your actions, please forward the completed Acknowledgement Form to Teleflex Customer Service at the contact details provided below. Important - Please ensure you only list lot numbers in scope of this recall notice when completing the Acknowledgement Form (Appendix 1). 4. If you have further distributed product outside of your country, please notify Teleflex Customer Service by return email to the email address provided below. Customer Service via Email: [email protected], Customer Service Telephone: 1-866-396-2111, or FAX: 1-855-419-8507. Customer Service hours of operation are 8am-7pm EST.

Recall details

Recall number

Z-0351-2023

Status

Terminated

Initiated by the company

Oct 27, 2022

Posted by the FDA

Dec 10, 2022

Recalling firm

ARROW INTERNATIONAL Inc.

Quantity

80 units

Product code

FOZ

FDA submissions

K071538, K002507

Distribution

US Distributor in states of: FL, GA, KY, OH, PA and WV.

Product description

Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• ARROW IPN055805

  Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days
  1 recall0 reports

Product lines

• ARROWTeleflex Incorporated · 1,494 models · 9,043 reports · 62 recalls

Other devices under the same FDA submission

246 devices cleared under K071538, K002507 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• ARROW IPN038522

  Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days
  3 recalls1 report
• ARROW IPN931283

  Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days
  3 recalls0 reports
• ARROW IPN931284

  Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days
  3 recalls0 reports
• ARROW IPN931286

  Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days
  3 recalls0 reports
• ARROW IPN036445

  Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days
  2 recalls8 reports
• ARROW IPN915628

  Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days
  2 recalls5 reports
• ARROW IPN915630

  Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days
  2 recalls2 reports
• ARROW IPN036474

  Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days
  2 recalls1 report
• ARROW IPN904896

  Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days
  2 recalls1 report
• ARROW IPN038523

  Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days
  2 recalls1 report
• ARROW IPN055818

  Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days
  2 recalls1 report
• ARROW IPN055820

  Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days
  2 recalls1 report

Other products in the same recall event

The FDA groups related products into one recall event (event 91090).

• Z-0352-2023 · Terminated
  Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d) ASK-45703-NS, e) ASK-45703-PAU, f) ASK-45703-…