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Epimed International Recall 88317

Description: NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile

Epimed International Recall 88317 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-2313-2021
Event ID88317
Event DescriptionNEO-KATH(TM) Caudal Set, REF 201-2430, Sterile
Product TypeDevices
DistributionWorldwide distribution, with US distribution to CA, DE, OH, OK, PA, VA, WA, WV. International distribution to Canada and Iran.
Quantity140 units
Recall ReasonPotential for stylet to protrude from the distal end of the catheter
Device Classification20210825
Device Code InfoReference Number 201-2430, Lot Numbers 16308139 (Expiration August 2022), 16308383 (Expiration October 2022)
Center Classification Date20210818
Recall Initiation Date20171228
Recalling FirmEpimed International
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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