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, peripherally inserted central catheters, and midline catheters into vascular system.
This recall has been terminated (originally issued December 21, 2013).
- Company
- B Braun Medical Inc
- Recall Initiated
- September 27, 2013
- Posted
- December 21, 2013
- Terminated
- October 8, 2014
- Recall Number
- Z-0559-2014
- Quantity
- 55,200 units
- Firm Location
- Allentown, PA
- Official Source
- View on FDA website ↗
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.
Distribution
USA Nationwide Distribution including Puerto Rico.
Lot / Code Info
lot no. 3C30258317
Root Cause
Labeling False and Misleading
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.