Device product
CATH TRAY; REF: DYNJ41101; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.
Z-1050-2014
Product summary
- Event
- Event 66080
- Status
- Terminated
- Classification
- Class I
- Quantity
- 304 units
- Official record key
device-enforcement:Z-1050-2014
Official wording
Reason: Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.
Code information: Pack Number: DYNJ41101; Lot: 13FB5744
Distribution pattern: Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.
Derived failure modes
-
Unknown
Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.