Recall Z-1552-2022

Stradis Medical, LLC dba Stradis Healthcare · initiated July 25, 2022

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

NARMD MEDICAL DEPOT Scissors Iris Curved 4.5", Part Number ZZ-0697

Codes / lots: SKU/Part Number: ZZ-0697; Lots: 22026482044 and 22152487922 UDI/DI: M752ZZ06970

Reason for recall

The sterile barrier may be compromised.

FDA-determined cause: Under Investigation by firm

Action taken

Stradis 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.

Details

Recall number
Z-1552-2022
Initiated
July 25, 2022
Product code
LRW – Scissors, General, Surgical
Quantity
50 units
Distribution
US Nationwide distribution in the state of SC.
Recalling firm
Stradis Medical, LLC dba Stradis Healthcare, Peachtree Corners, GA

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1553-2022 Class IINARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"; Part Number: ZZ-0700The sterile barrier may be compromised. 07/25/2022Open, Classified
Z-1554-2022 Class IINARMD MEDICAL DEPOT Forceps - Kelly Curved 5.5"; Part Number: ZZ-0701The sterile barrier may be compromised. 07/25/2022Open, Classified