Devices

Device Recall 60 mL Sryinge, MR, w/lateral flow needle.

Model / Serial
Catalog #: 801104; Lot #s: 0001110, 0067041, 0074024, 0130214, 0155164, 0162121, 0278106, 0344212, 0351225, 1021271, 1210163, 1336343, 9058252, 9121110, 9212120, 9260020, 9302042, 9317041
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA including Distributed worldwide: USA including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY, Puerto Rico and the countries of Canada, Australia, Belgium, Brazil, Chile, Ecuador, Guatemala, Mexico, Panama, Singapore, and Uruguay.
Product Description
Liebel-Flarsheim Optistar MR 60 mL Syringe w/lateral flow needle, Mallinckrodt, Cincinnati, OH 45237. Made in Mexico. Devices packaged in Plastic and Tyvec pouch, with 50 pouches per case. || Sterile, The purpose of this product is the injection of contrast media by means of power injector system during a diagnostic procedure.
Manufacturer
Mallinckrodt Inc
1 Event
- Recall of Device Recall 60 mL Sryinge, MR, w/lateral flow needle.

Manufacturer

Mallinckrodt Inc

Manufacturer Address
Mallinckrodt Inc, 2111 E Galbraith Rd, Cincinnati OH 45237-1624
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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