Epimed International Recall 88317
Description: NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile
Epimed International Recall 88317 Information
Status | Completed |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-2313-2021 |
Event ID | 88317 |
Event Description | NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile |
Product Type | Devices |
Distribution | Worldwide distribution, with US distribution to CA, DE, OH, OK, PA, VA, WA, WV. International distribution to Canada and Iran. |
Quantity | 140 units |
Recall Reason | Potential for stylet to protrude from the distal end of the catheter |
Device Classification | 20210825 |
Device Code Info | Reference Number 201-2430, Lot Numbers 16308139 (Expiration August 2022), 16308383 (Expiration October 2022) |
Center Classification Date | 20210818 |
Recall Initiation Date | 20171228 |
Recalling Firm | Epimed International |
Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
Similar To |