Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
Reported: June 27, 2012 Initiated: May 9, 2012 #Z-1844-2012
Product Description
Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
Reason for Recall
Potential for the sterility barrier to be compromised.
Details
- Recalling Firm
- Covidien LP
- Units Affected
- 50698 units
- Distribution
- Worldwide distribution: USA (Nationwide) and countries including; Africa, Argentina, Australia, Belgium, Brazil, Canada, China Costa Rica, CROATIA, Czech Republic,Dominion Republic, ESPA¿A France, Germany, Greece Guadeloupe, Guatemala, Honduras Hong Kong, Hungary, India, Indonesia, Ireland, Italy, Japan, Korea ,Malaysia, Mexico, Peru, Portugal, Puerto Rico, Spain, Sri Lanka, Switzerland, Taiwan , Thailand, and UK.
- Location
- North Haven, CT
Frequently Asked Questions
What product was recalled? ▼
Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis. Recalled by Covidien LP. Units affected: 50698 units.
Why was this product recalled? ▼
Potential for the sterility barrier to be compromised.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 27, 2012. Severity: Moderate. Recall number: Z-1844-2012.
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