MEDRAD Sterile Disposable Syringe Kit Recall, Catalog Number 150-FT-Q; Kit includes angiographic injector and syringe Th

FDA device recall Z-0367-2011 · posted 2010-11-15 · Terminated

Recall details

Recalling firm

Medrad Inc

Reason for recall

Some kits have a hole in the packaging which could compromise the sterility of the components.

Action taken

MEDRAD issued an URGENT MEDICAL DEVICE RECALL letter dated May 17, 2010, to all affected customers. The letter identified the product, the problem, and the action the customer should take. Customers were instructed to identify the product with the affected lot numbers. Contact MEDRAD Customer Support at 1-800-633-7231 to make arrangements for the return of the product. Complete and sign the form attached to the letter and fax it back to MEDRAD at 412-406-0942. For any questions regarding this recall call (412) 767-2400, ext 6851.

Root cause

Packaging

Status

Terminated

Product code

DXT

Quantity affected

39,448 syringe kits

Distribution

Worldwide Distribution - USA including AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO MS, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, an

Date initiated

2010-05-17

Date posted

2010-11-15

Date terminated

2010-11-17

Location

Warrendale, PA