FDAFDA · Food and drugs·Recall number Z-2237-2015
Medical Device Exchange Wire (sternotomy wire); Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 046-072; 046-073; EXP (repackager), A & E Medical (OEM) Suture, nonabsorbable
Published August 5, 2015 · Recall initiated: February 11, 2015
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
EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- EXP Pharmaceutical Services Corp
- Distributor
- Distributed in DC and the states of CO, CA, FL, TX, and AR.
- Lot
- OEM Catalog number 046-072; 046-073.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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