Recall Z-0559-2014— B. Braun Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by B. Braun Medical, Inc., initiated 2013-09-27, terminated 2014-10-08. It names one FDA 510(k) clearance: K021094. Product: 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.. 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..
- Recalling firm
- B. Braun Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-09-27
- Terminated
- 2014-10-08
- Firm location
- Allentown, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.