mcompass 2-channel Balloon Catheters The mcompass recall
mcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressure studies.…
Why was mcompass 2-channel Balloon Catheters The mcompass recalled?
Potential failure in the balloon bond in the inner catheter stem, leading to the separation of the balloon from the inner stem, leaving it in the rectal cavity.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part # RMD-002-004 Lot No #'s 160627-10 and 160627-11.
- Product
- mcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressure studies.…
- Recalling firm
- Medspira, Llc
- Quantity
- 355 catheters (255 US - 100 foreign. )
- Distribution
- Worldwide Distribution - US Distribution to the states of :CA, FL, IA, ID, and TX., and to the countries of : Austria, Italy, Malaysia, Philippines, Sweden, and United Kingdom
- Recall date
- September 6, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)