Recall Z-0797-2010 ยท ETD Tube, Tympanostomy
Gyrus ACMI Corporation
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.
| Date | Mar 4, 2010 (initiated Jan 8, 2010) |
| Status | Terminated |
| Reason | Units of the product in lot MH136952 may have been shipped without being sterilized. |
| Root cause | Pending |
| Action | 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. Que |
| Quantity | 19 boxes of 6 units |
| Distribution | Nationwide Distribution -- Including states of FL, GA, OH, TX, RI, IL, MI, and KS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K820362 | REUTER BOBBIN VENTILA. TUBE-TITANIUM Richard'S Medical Equip., Inc., Mar 2, 1982 |