—#182559

Product

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

FDA product code: CAZ — Anesthesia Conduction Kit
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K801912
Affected lot / code info: Product Code: EC-05000 Lot #: 13F18C0518

Why it was recalled

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.

Root cause (FDA determination)

Incorrect or no expiration date

Action the firm took

Arrow sent a customer notification letter dated July 6, 2020. This letter informed customers of the affected product, asked them to check and remove inventory, and complete the response form.

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Rd, Reading, Pennsylvania 19605-9607

Distribution

Distribution pattern: World wide distribution

Timeline

Recall initiated: 2020-07-06
Terminated: 2021-11-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #182559. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.