FDA Recalls Covidien ROTICULATOR Staplers Due to Sterility Barrier Risk
The FDA is recalling specific lots of Covidien ROTICULATOR 55-3.5 Single Use Staplers because the sterility barrier may be compromised, posing a risk of infection during surgery.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of infection from a compromised sterility barrier in a surgical device.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for specific lots of the Covidien ROTICULATOR 55-3.5 Single Use Stapler (REF# 017612). The recall is due to a potential for the sterility barrier to be compromised, which could result in the device not being sterile when used.
The affected product is used in abdominal, gynecologic, and pediatric surgery for resection, transection, and creation of anastomosis. The recall covers 50,698 units distributed worldwide, including the United States and numerous international markets. Specific lot numbers are identified in the recall notice, with certain lots ending in "RMX" and "RRMX" explicitly noted as not affected and acceptable for use.
Healthcare providers and facilities should stop using the affected lots immediately and contact the manufacturer for instructions on return or replacement. Patients who have had surgery using these specific devices should consult their healthcare provider if they have concerns about potential infection.
The recalled product
- Product
- 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
- Manufacturer
- Covidien LP
- Affected units
- 50,698
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- OOZ0976
- OOZ1401
- OOZ1407
- OOB0117
- P2B0488XR
- P2B0153XR
Distribution
Part of a larger recall action
This product is one of 5 recalled by Covidien LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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