Recall Z-0643-2014— Smiths Medical ASD, Inc.
Class II · Terminated
Class II FDA medical device recall by Smiths Medical ASD, Inc., initiated 2013-07-10, terminated 2021-09-15. It names one FDA 510(k) clearance: K063755. Product: Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.3ml 29g x 1/2 in Reference: 4429-3 Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.. Reason: Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes.
- Recalling firm
- Smiths Medical ASD, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-07-10
- Terminated
- 2021-09-15
- 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
Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.3ml 29g x 1/2 in Reference: 4429-3 Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.
Reason for recall
Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes
Data sourced from openFDA. This site is unofficial and independent of the FDA.