MICRON BOBBIN VENT TUBE, 1.27 MM I.D., TITANIUM, REF 145281-ENT, QTY 1, STERILE EO, GYRUS ACMI INC., 136 TURNPIKE ROAD,
FDA device recall Z-0797-2010 · posted 2010-03-04 · Terminated
Recall details
- Recalling firm
- Gyrus ACMI Corporation
- Reason for recall
- Units of the product in lot MH136952 may have been shipped without being sterilized.
- 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.
- Root cause
- Pending
- Status
- Terminated
- Product code
- ETD
- Quantity affected
- 19 boxes of 6 units
- Distribution
- Nationwide Distribution -- Including states of FL, GA, OH, TX, RI, IL, MI, and KS.
- Date initiated
- 2010-01-08
- Date posted
- 2010-03-04
- Date terminated
- 2010-07-27
- Location
- Southborough, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REUTER BOBBIN VENTILA. TUBE-TITANIUM (K820362) | Richard'S Medical Equip., Inc. | 1982-03-02 |