Arrow International Inc: The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection or other complications. Sterility, biocompatibility, safety, or efficacy of the kits and their components are not assured beyond the correct expiration date.

Agency Publication Date: August 13, 2020

Affected Products

Product: Arrow Single Shot Epidural Anesthesia Kit - Product Usage: The Arrow Blunt Needle Single Shot Epidural Kit permits access to the epidural space.

Product Code: AK-03000-S Lot #: 13F17J0230

Lot Numbers:

AK-03000-S

13F17J0230

Product: Cannon II Plus Replacement Hub Set - Product Usage: is indicated for use in the replacement of a Cannon II Plus hub connection assembly that has been damaged.

Product Code: CAR-02400 Lot #: 13F19J0153 and 23F17H0547

Lot Numbers:

CAR-02400

13F19J0153

Product: Arrow TheraCath Epidural Catheter - Product Usage: The Arrow Epidural Catheter permits access to the epidural space.

Product Code: EC-05000 Lot #: 13F18C0518

Lot Numbers:

EC-05000

13F18C0518

Product: NextStep Retrograde Replacement Hub Set - Product Usage: is indicated for use in the replacement of a NextStep Retrograde hub connection assembly that has been damaged.

Product Code: NRH-15192 Lot #: 13F19H0454

Lot Numbers:

NRH-15192

13F19H0454

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86044

Status: Resolved

Manufacturer: Arrow International Inc

Manufactured In: United States

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Product: Arrow Single Shot Epidural Anesthesia Kit - Product Usage: The Arrow Blunt Needle Single Shot Epidural Kit permits access to the epidural space.

Product Code: AK-03000-S Lot #: 13F17J0230

Lot Numbers:

AK-03000-S

13F17J0230

Product: Cannon II Plus Replacement Hub Set - Product Usage: is indicated for use in the replacement of a Cannon II Plus hub connection assembly that has been damaged.

Product Code: CAR-02400 Lot #: 13F19J0153 and 23F17H0547

Lot Numbers:

CAR-02400

13F19J0153

Product: Arrow TheraCath Epidural Catheter - Product Usage: The Arrow Epidural Catheter permits access to the epidural space.

Product Code: EC-05000 Lot #: 13F18C0518

Lot Numbers:

EC-05000

13F18C0518

Product: NextStep Retrograde Replacement Hub Set - Product Usage: is indicated for use in the replacement of a NextStep Retrograde hub connection assembly that has been damaged.

Product Code: NRH-15192 Lot #: 13F19H0454

Lot Numbers:

NRH-15192

13F19H0454