B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 4251601-02. Product Usage: The B. Braun Introc
FDA device recall Z-0559-2014 · posted 2013-12-21 · Terminated
Recall details
- Recalling firm
- B. Braun Medical, Inc.
- Reason for recall
- One lot of Introcan Safety IV Catheters may not contain the anti-needlestick safety clip which is used for the prevention of needlestick injuries.
- Action taken
- B. Braun sent an Urgent Medical Device Recall Notification letter dated September 27, 2013 to all affected customers. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to utilize the attached "Product Removal Acknowledgement Form" to record the number of individual units in their inventory and fax the completed form to 610-848-1197. To ensure proper credit for affected product, customers were instructed to return the product to B. Braun Medical Inc. For questions contact Customer Support Department at 800-227-2862.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 55,200 units
- Distribution
- USA Nationwide Distribution including Puerto Rico.
- Date initiated
- 2013-09-27
- Date posted
- 2013-12-21
- Date terminated
- 2014-10-08
- Location
- Allentown, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTROCAN SAFETY IV CATHETER (K021094) | B.Braun Medical, Inc. | 2002-07-03 |