Arrow IPN036765

• FDA 510(k) K112896 decided 10 May 2012 Active
• FDA GUDID UDI-DI 10801902124002 listed 16 Sep 2016 Listed

• • Ongoing Z-2378-2026 FDA Class I ·initiated 21 Apr 2026

  Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

• 4 recalls, same reason

  • Terminated Z-1822-2019 FDA Class II ·initiated 23 Apr 2019
  • Terminated Z-1820-2019 FDA Class II ·initiated 23 Apr 2019
  • Terminated Z-1811-2019 FDA Class II ·initiated 23 Apr 2019
  • Terminated Z-1819-2019 FDA Class II ·initiated 23 Apr 2019

  Lidstock states the incorrect expiration date for the product

• • Terminated Z-1327-2018 FDA Class II ·initiated 22 Dec 2017 ·on shared 510(k) K112896

  Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

• • Terminated Z-0996-2018 FDA Class II ·initiated 27 Nov 2017

  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.

• • Terminated Z-2698-2017 FDA Class II ·initiated 12 Jun 2017

  Arrow is recalling additional lots that were identified as part of an active recall. Arrow is recalling the affected product due to the possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter.

• • Terminated Z-2331-2017 FDA Class II ·initiated 9 May 2017

  Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.

• • Terminated Z-1705-2017 FDA Class II ·initiated 3 Mar 2017

  Arrow International, Inc. notified its customers who received the affected Antimicrobial/Antithrombogenic PICC Kits, that the kits were being recalled due to a labeling error. The lidstock on some of the kits reads CDC-45541-HPK1A, while the banner card on the side of the kit reads CDC-45052-HPK1A. Other kits may list CDC-45052-HPK1A on the lidstock and CDC-45541-HPK1A on the banner card. The affected lot numbers are 23F16C0851, 23F16A0727, and 23F16C0844.

• • Terminated Z-0207-2016 FDA Class II ·initiated 16 Oct 2015

  Possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter. Although the issue does not pose a significant risk to the patient, it may cause a delay of treatment when placing the catheter.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1. 3 Mar 2017 Recall initiated FDA recalls Z-1705-2017
2. 9 May 2017 Recall initiated FDA recalls Z-2331-2017
3. 12 Jun 2017 Recall initiated FDA recalls Z-2698-2017
4. 27 Nov 2017 Recall initiated FDA recalls Z-0996-2018
5. 22 Dec 2017 Recall initiated FDA recalls Z-1327-2018
6. 23 Apr 2019 Recall initiated FDA recalls Z-1822-2019
7. 23 Apr 2019 Recall initiated FDA recalls Z-1820-2019
8. 23 Apr 2019 Recall initiated FDA recalls Z-1811-2019
9. 23 Apr 2019 Recall initiated FDA recalls Z-1819-2019
10. 21 Apr 2026 Recall initiated FDA recalls Z-2378-2026

3 earlier events are in the sections above.

Trade name

Arrow

Generic name

Peripherally-inserted central venous catheter

Model / Ref / Catalog

IPN036765, CDC-44052-HPK1A

Primary DI / UDI-DI

10801902124002

510(k) Number

K112896 ↗

FDA product code

LJS

GMDN term

Peripherally-inserted central venous catheter

Device class

Class II

Regulation number

880.5970

GUDID distribution status

In Commercial Distribution

Category: Peripherally-inserted central venous catheter

Other devices filed under FDA product code LJS (Catheter,intravascular,therapeutic,long-term greater than 30 days).

• Vygon PICCs by Vygon USA
• C3 Wave System by Medical Components, Inc. (dba MedComp)
• 3F PRO-PICC by Medical Components, Inc.
• SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET by Cook, Inc.
• MEDCOMP H-CATH TRIPLE LUMEN CENTRAL VENOUS ACCESS CATHETER, MODEL SIC 12-3T by Medical Components, Inc.
• PRO-LINE CT POWER INJECTABLE CVC, MODELS CTLINES5S, CTLINE6D by Medcomp
• Celerity PICC Tip Confirmation System by ANGIODYNAMICS, INC.
• 4 FR SINGLE LUMEN (SL) POWERPICC CATHETER by C. R. Bard, Inc.
• MEDCOMP BIO-CATH CATHETER LINE by Medcomp
• Silicone Peripherally Inserted Central Venous Catheter Set/Tray by COOK INCORPORATED

• Arrow IPNB00820 Open recall

  Class II

  FDA 510(k) K140110 Active Cleared 27 Mar 2015 GUDID on market

• Arrow IPNB00826 Open recall

  Class II

  FDA 510(k) K140110 Active Cleared 27 Mar 2015 GUDID on market

• Arrow IPNB00822 Open recall

  Class II

  FDA 510(k) K140110 Active Cleared 27 Mar 2015 GUDID on market

• Arrow IPNB00827 Open recall

  Class II

  FDA 510(k) K140110 Active Cleared 27 Mar 2015 GUDID on market

See all devices from Teleflex Incorporated →