Banyan Medical Pyramidal Tip Trocar Recalled for Sterility Concerns
Banyan Medical is recalling 5 x 55mm Pyramidal Tip Trocars due to a potential lack of assurance of sterility. The recall affects 64 boxes distributed in Indiana and Tennessee.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall is classified as FDA Class II. The hazard involves a potential lack of sterility assurance for a medical device, which poses a risk of harm, but the source text does not report any specific illnesses or injuries.
Plain-English summary
Banyan Medical, LLC is recalling 64 boxes of 5 x 55mm Pyramidal Tip Trocars with 2X Cannula with Sideport, intended for laparoscopic use. The product is sterile and for single use only. The recall is being conducted due to a potential lack of assurance of sterility.
The affected product is identified by Product Code 400-009 and Lot Numbers 140718 and 160209. The recall covers 64 boxes of 5 units each. Distribution was limited to the states of Indiana and Tennessee.
Healthcare providers and consumers should stop using the affected trocars immediately. Users should contact Banyan Medical, LLC for further instructions regarding the return or disposal of the product.
The recalled product
- Product
- Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/ Sideport. Laproscopic Use- Sterile Single Use Only Product Code 400-009
- Manufacturer
- Banyan Medical, LLC
- Hazard
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 (2)
- Lot Numbers:140718
- 160209
Distribution
Part of a larger recall action
This product is one of 2 recalled by Banyan Medical, LLC 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.
See all 2 products in this recall →Related recalls
Same manufacturer · Banyan Medical, LLC
See all →- HighBanyan Medical Pyramidal Trocar Recalled for Potential Sterility Issues
FDA (Devices) · 2016-10-19
Same hazard · sterility failure
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