Recall Z-0559-2014 ยท DYB Introducer, Catheter
B. Braun Medical, Inc.
B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 4251601-02. Product Usage: The B. Braun Introcan Safety IV Catheter is a passive anti-stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of vascular access devices such as guidewires, indwelling central venous catheters, peripheral
| Date | Dec 21, 2013 (initiated Sep 27, 2013) |
| Status | Terminated |
| Reason | One lot of Introcan Safety IV Catheters may not contain the anti-needlestick safety clip which is used for the prevention of needlestick injuries. |
| Root cause | Labeling False and Misleading |
| Action | 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. |
| Quantity | 55,200 units |
| Distribution | USA Nationwide Distribution including Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021094 | INTROCAN SAFETY IV CATHETER B.Braun Medical, Inc., Jul 3, 2002 |