Smiths Medical Recalls Hypodermic Needles Due to Syringe Hub Defects
Smiths Medical is recalling specific lots of Jelco Hypodermic Needle Pro needles because syringe assemblies used in their manufacture contained pin holes in the hub.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the defect (pin holes in syringe hubs) presents a risk of harm to patients, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Smiths Medical ASD Inc. is recalling 736,000 units of Jelco Hypodermic Needle Pro needles, specifically Model No. EL 1915 and Model No. SB 5021. The affected products are sterile, ethylene oxide (EO) sterilized, and prescription-only (Rx Only) devices. The recall covers specific lot codes: 3297460, 3297461 for Model EL 1915, and 3297458, 3297459, 3297465, 3297466, 3297467 for Model SB 5021.
The recall was initiated after 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. This defect was not detected during Smiths Medical's incoming inspection. These defective syringe assemblies were used to manufacture seven finished good lots of the affected hypodermic needles.
The affected products were distributed in the United States to the state of Indiana. No illnesses or injuries have been reported in the source text. Consumers and healthcare providers should check their inventory for the specific model numbers and lot codes listed above and stop using these products if they match the recall criteria.
The recalled product
- Product
- 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.
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 736,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 3297460
- 3297461 Model No. EL1915. 3297458
- 3297459
- 3297465
- 3297466
- 3297467 Model No. SB5021.
Distribution
Distributed in 1 state:
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