RX-2 COUDE Epidural Needle recall: Sterility Concern
RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, For Use with…
Why was RX-2 COUDE Epidural Needle recalled?
Potential for partially incomplete seal of product, impacting sterility.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot No. 12168200; Ref No. 107-1416.
- Product
- RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, For Use with…
- Recalling firm
- Epimed International
- Quantity
- 500 units
- Distribution
- Domestic: AR, CA, IA, IN, KY, LA, MI, NY, OH, OR, TN, TX, & WA. Foreign: Canada, Czech Republic, Germany ,& Turkey.
- Recall date
- November 15, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)