Z-2670-2017 Class II Terminated
FDA device recall Z-2670-2017 was initiated by Smiths Medical ASD Inc. on April 4, 2017 and is designated Class II. Reason for recall: Smiths Medical became aware on January 11, 2017, that syringe assemblies provided by Nipro Medical Corporation contained pin holes in the side wall of the hub. The defect was not detected during Smith… The recall status is terminated (terminated August 5, 2019). Affected quantity: 736,000.
Recall Details
- Product Type
- Devices
- Report Date
- July 12, 2017
- Initiation Date
- April 4, 2017
- Termination Date
- August 5, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 736,000
Product Description
Jelco, Hypodermic needle Pro¿ needles 19G X1 1/2" 800/CA Model No. EL 1915 & 19G X 2" 600/CA Model No. SB 5021, Rx Only, Sterile EO.
Reason for Recall
Smiths Medical became aware on January 11, 2017, that syringe assemblies provided by Nipro Medical Corporation contained pin holes in the side wall of the hub. The defect was not detected during Smiths Medical incoming inspection. The syringe assemblies were used to manufacture seven (7) finished good lots of Hypodermic Needle Pro¿ needles, Smiths Medical part numbers EL 1915 and SB5021.
Distribution Pattern
US Distribution to the state of : IN
Code Information
3297460,3297461 Model No. EL1915. 3297458,3297459,3297465, 3297466,3297467 Model No. SB5021.