Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and Head and Neck procedures. Catalog No. TS101DC, Lot numbers JC924165 and below; Rx Only, STERILE EO
This recall has been terminated (originally issued June 11, 2015).
- Company
- Gyrus Acmi, Incorporated
- Recall Initiated
- May 8, 2015
- Posted
- June 11, 2015
- Terminated
- May 17, 2016
- Recall Number
- Z-1753-2015
- Quantity
- 22,250 boxes
- Firm Location
- Southborough, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential lack of sterility assurance.
Distribution
Nationwide and Canada, Australia, Germany, New Zealand, Japan, India, Great Britain
Lot / Code Info
Lot Number: JC24165
Root Cause
Under Investigation by firm
Action Taken
The firm notified their direct accounts of the recall by Fed Ex Second Day on 05/08/2015. The letter requesting disposal of the product was extended to hospitals or medical practices that purchased the product. Non-responding consignees will be contacted again if necessary.
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