Z-0086-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 9, 2016
- Initiation Date
- April 22, 2016
- Termination Date
- June 14, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 576 units
Product Description
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
Reason for Recall
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.
Distribution Pattern
US Distribution to the states of : AL, AK, FL, IN, TN & TX
Code Information
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)