Recalls / —
—#182560
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.
- FDA product code
- NFK — Kit, Repair, Catheter, Hemodialysis
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- 510(k) numbers
- K020430
- Affected lot / code info
- Product Code: NRH-15192 Lot #: 13F19H0454
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 #182560. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.