PlainRecordsFDA · Medical device recall
NARMD MEDICAL DEPOT Scissors Iris Curved 4.5"… and 2 more products
- Date
- Aug. 24, 2022
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing
- Filed by
- Stradis Medical, LLC dba Stradis Healthcare
- Reason
- The sterile barrier may be compromised.
- Distribution pattern
- US Nationwide distribution in the state of SC.
3 products in this recall
NARMD MEDICAL DEPOT Scissors Iris Curved 4.5"…
- Product
- NARMD MEDICAL DEPOT Scissors Iris Curved 4.5", Part Number ZZ-0697
- Quantity
- 50 units
- Codes and lots
- SKU/Part Number: ZZ-0697; Lots: 22026482044 and 22152487922 UDI/DI: M752ZZ06970
- Recall started
- July 25, 2022
- Device type
- Scissors, General, Surgical
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- 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.
- Recall number
- Z-1552-2022
NARMD MEDICAL DEPOT Forceps…
- Product
- NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"; Part Number: ZZ-0700
- Quantity
- 825 units
- Codes and lots
- SKU/Part Number: ZZ-0700; Lots: 22145487092 and 22154486659 UDI/DI: M752ZZ07000
- Recall started
- July 25, 2022
- Device type
- Forceps
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- 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.
- Recall number
- Z-1553-2022
NARMD MEDICAL DEPOT Forceps…
- Product
- NARMD MEDICAL DEPOT Forceps - Kelly Curved 5.5"; Part Number: ZZ-0701
- Quantity
- 850 units
- Codes and lots
- SKU/Part Number: ZZ-0701; Lots: 22027483172 and 22131487071 UDI/DI: M752ZZ07010
- Recall started
- July 25, 2022
- Device type
- Forceps
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- 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.
- Recall number
- Z-1554-2022
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-1552-2022, Z-1553-2022, Z-1554-2022. The agency record governs; check it and the company before acting.