FDAFDA · Food and drugs·Recall number Z-1049-2014
CATH LAB CUSTOM PACK; REF: DYNJ40926; 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.
Published March 5, 2014 · Recall initiated: August 14, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medline Industries, Inc.
- Distributor
- Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.
- Lot
- Pack Number: DYNJ40926; Lot: 13FB4759
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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