Recall Z-0927-03 ยท KOH Instrument, Manual, General Obstetric-Gynecologic
Portex, Inc
Bivona brand Adjustable Hyperflex Tracheostomy Tube, Pediatric, cuffless; catalog # 60HA40.
| Date | Jun 12, 2003 (initiated Feb 20, 2003) |
| Status | Terminated |
| Reason | May have incorrectly printed graduation markings along the tube shaft. |
| Root cause | Other |
| Action | A recall letter dated February 20, 2003 was issued to each customer. Customers were instructed to cease use of the lot and to return the product to Portex. |
| Quantity | 49 |
| Distribution | Nationwide, England and France |
| FDA record | Open on fda.gov |