MICRON BOBBIN VENT TUBE, 1.27 MM I.D., TITANIUM, REF 145281-ENT, QTY 1, STERILE EO, GYRUS ACMI INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01772 USA. Intended to be implanted for ventilation or drainage of the middle ear.
This recall has been terminated (originally issued March 4, 2010).
- Company
- Gyrus Acmi Corporation
- Recall Initiated
- January 8, 2010
- Posted
- March 4, 2010
- Terminated
- July 27, 2010
- Recall Number
- Z-0797-2010
- Quantity
- 19 boxes of 6 units
- Firm Location
- Southborough, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Units of the product in lot MH136952 may have been shipped without being sterilized.
Distribution
Nationwide Distribution -- Including states of FL, GA, OH, TX, RI, IL, MI, and KS.
Lot / Code Info
Lot Number: MH136952.
Root Cause
Pending
Action Taken
The firm initiated their recall on 01/04/2010 by telephone or visit to their consignees. A follow-up Urgent: Medical Device Recall correspondence, dated 1/14/2010, was sent on 01/27/2010, return receipt requested, to both the consignees and the implanting surgeons. The follow-up letter identified the affected product and described the issue. Customers are to immediately cease any further use of any affected product and quarantine it. Also, they are to obtain a Return Goods Authorization and return the affected product to the firm. The reply form should be completed and also returned. Questions should be directed to customer service at 1-800-773-4301.