Recall Z-0897-2015— Smiths Medical ASD, Inc.
Class II · Completed
Class II FDA medical device recall by Smiths Medical ASD, Inc., initiated 2014-11-21. It names one FDA 510(k) clearance: K041399. Product: Hypodermic Needle Pro¿ Edge" Safety Device 20G x1; Reorder Number: 402010 Product Usage: The Needle Pro¿ Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.. Reason: Needle is not captured in the needle safety sheath in specific lots..
- Recalling firm
- Smiths Medical ASD, Inc.
- Classification
- Class II
- Status
- Completed
- Initiated
- 2014-11-21
- Firm location
- Keene, NH, 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
Hypodermic Needle Pro¿ Edge" Safety Device 20G x1; Reorder Number: 402010 Product Usage: The Needle Pro¿ Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.
Reason for recall
Needle is not captured in the needle safety sheath in specific lots.
Data sourced from openFDA. This site is unofficial and independent of the FDA.