ClearanceBrief
Recall Z-1553-2022 ยท HTD Forceps

Stradis Medical, LLC dba Stradis Healthcare

NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"; Part Number: ZZ-0700

DateJul 25, 2022
StatusOpen, Classified
ReasonThe sterile barrier may be compromised.
Root causeUnder Investigation by firm
ActionStradis notified its sole consignee on 07/25/2022 by email. The notice explained the reason for the recall and the hazard, and requested the consignee contact customer service to arrange for the return and credit of the affected product. Should the product be further distributed, the consignee was directed to notify its customers within 48 hours of receipt of the notice. Those customers were directed to contact Stradis directly to arrange return and credit.
Quantity825 units
DistributionUS Nationwide distribution in the state of SC.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.