Aesculap Disposable Trocars with Dilating Pins Recalled for Packaging Damage
Aesculap Inc is recalling disposable trocars with dilating pins due to potential sterile blister packaging damage that may compromise sterility. The affected product (code EK236SU) was distributed in the US and Canada.
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: This is a risk-of-harm product (sterile surgical instruments used in invasive procedures) where injury has not yet been reported. The potential for serious post-operative infection from non-sterile surgical devices in a Class II recall justifies a High severity rating.
Plain-English summary
Aesculap Inc is recalling the Disposable Trocar with Dilating Pin (12/110mm, Product Code EK236SU) used in laparoscopic surgical procedures. The recall was initiated due to potential damage to the sterile blister packaging, which may compromise the sterility of the device.
The affected batch is 52580815 with an expiration date of December 8, 2023. The product was distributed worldwide, with US distribution in Kansas, New Jersey, and New York, as well as in Canada.
Non-sterile surgical instruments could pose a risk of serious infection when used in surgical procedures. Hospitals and surgical centers that received affected units should stop using them and contact Aesculap Inc for instructions on return or disposal.
Patients who have undergone laparoscopic procedures using potentially affected devices should consult with their healthcare provider if they experience signs of infection, such as fever, wound pain, redness, or discharge.
The recalled product
- Product
- DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic procedures.
- Manufacturer
- Aesculap Inc
- Affected units
- 6
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 (3)
- Product Code: EK236SU
- UDI/DI: 04046963620479
- Batch Numbers (Expiration Date): 52580815 (12/08/2023)
Distribution
Part of a larger recall action
This product is one of 5 recalled by Aesculap Inc 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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