TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only
Reported: November 15, 2017 Initiated: July 24, 2017 #Z-0089-2018
Product Description
TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only
Reason for Recall
Potential for partially incomplete seal of product, impacting sterility.
Details
- Recalling Firm
- Epimed International
- Units Affected
- 263 units
- Distribution
- Domestic: AR, CA, IA, IN, KY, LA, MI, NY, OH, OR, TN, TX, & WA. Foreign: Canada, Czech Republic, Germany ,& Turkey.
- Location
- Farmers Branch, TX
Frequently Asked Questions
What product was recalled? ▼
TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only. Recalled by Epimed International. Units affected: 263 units.
Why was this product recalled? ▼
Potential for partially incomplete seal of product, impacting sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 15, 2017. Severity: Moderate. Recall number: Z-0089-2018.
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