Recall Z-1054-2014— Medline Industries, Inc.
Class I · Terminated
Class I FDA medical device recall by Medline Industries, Inc., initiated 2013-08-14, terminated 2017-12-19. FDA's recall record names no specific 510(k) clearance for this event. Product: STERILE SAMPLE BUILD; REF: SAMP0147; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.. 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..
- Recalling firm
- Medline Industries, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2013-08-14
- Terminated
- 2017-12-19
- Firm location
- Waukegan, IL, United States
Product description
STERILE SAMPLE BUILD; REF: SAMP0147; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.