Reported Nov 9, 2016 · Terminated
15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural placement, directly or through an…
Epimed International, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Epimed International, Inc. · 141 Sal Landrio Dr · Johnstown, NY · 12095-3835
Is this the product you have?
- 15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia
- Lot codes and dates
3 of 3 products
Products covered by this recall # Product as published 1 Spectra Lot# GC091702 (Epimed manufacturing lot # 2801501, Sterile Lot # 12157181) 2 Spectra Lot# GC101871 (Epimed manufacturing lot # 3211503, Sterile Lot # 12157445) 3 Spectra Lot# GC101897 (Epimed manufacturing lot # 3161501, Sterile Lot # 12157325) - Amount recalled
- 576 units
Where it was sold
Why it was recalled
There is a possibility that the needles may have the potential to skive a catheters outer coating. If this were to occur, there exists the risk that a portion of the catheter could remain in the patient, which may require otherwise unnecessary medical invention.
This product could cause temporary or reversible health problems — stop using it.
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