Arrow NextStep Antegrade Chronic Hemodialysis Catheter. Product is used for attaining long-term vascular access for hemo
FDA device recall Z-2883-2011 · posted 2011-07-30 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- Firm has received complaints indicating breakage and/or separation of the stylet within the Arrow(R) NextStep(R) Antegrade Catheters.
- Action taken
- An "Urgent Medical Device Recall" letter dated June 28, 2011 was issued to consignees. The letter requested that customers check their stock, cease use and distribution, and quarantine all affected product. Consignees were further directed to complete the "Recall Acknowledgement & Stock Status Form", return the form to their sales representative, and return affected product as instructed on the letter. For questions or concerns, call 1-800-233-3187.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MSD
- Quantity affected
- 41
- Distribution
- United States (states of CA, DE, FL, MI, NC, and TN).
- Date initiated
- 2011-06-28
- Date posted
- 2011-07-30
- Date terminated
- 2012-04-16
- Location
- Reading, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARROW(R) NEXTSTEP TM ANTEGRADE CHRONIC HEMODIALYSIS CATHETER (K102238) | Teleflexmedical, Inc. | 2011-02-01 |