Aesculap MINOP trocar shafts may be longer than specified
Aesculap is recalling MINOP Trocar 150 mm with 6.0 mm working channel, model FF399R, because of the potential for the trocar shaft to be too long.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: an out-of-specification shaft length on a surgical access device is a hazard during a procedure, and no injuries are stated in the source.
Plain-English summary
Aesculap Inc is recalling the MINOP Trocar 150MM 4 WKING CHANNEL 6.0MM, model FF399R. About 126 units were distributed across 31 US states. The FDA has classified this recall as Class II.
There is the potential for the length of the trocar shaft to be too long.
Affected product carries UDI-DI 04038653065547, across 128 listed serial numbers beginning 4592.
Facilities can identify affected devices by the model number, UDI and serial numbers above, and may contact Aesculap Inc for further information.
The recalled product
- Product
- Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Version: N/A Product Description: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Component: N/A
- Manufacturer
- Aesculap Inc
- Category
- Medical Device — Surgical
- Hazard
- dimensional-defect
- surgical-risk
- out-of-specification
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 (20)
- Mode No. FF399R
- UDI-DI 04038653065547
- Serial Numbers: 4595
- 4619
- 4657
- 4764
- 4592
- 4596
- 4598
- 4601
- 4606
- 4607
- 4608
- 4612
- 4616
- 4618
- 4620
- 4621
- 4623
- 4659
Distribution
Distributed nationwide across the United States.
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