Bivona brand Adjustable Hyperflex Tracheostomy Tube, Pediatric, cuffless; catalog # 60HA40.
FDA device recall Z-0927-03 · posted 2003-06-12 · Terminated
Recall details
- Recalling firm
- Portex, Inc
- Reason for recall
- May have incorrectly printed graduation markings along the tube shaft.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- KOH
- Quantity affected
- 49
- Distribution
- Nationwide, England and France
- Date initiated
- 2003-02-20
- Date posted
- 2003-06-12
- Date terminated
- 2003-12-10
- Location
- Gary, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIVONA HYPERFLEX TRACHEOSTOMY TUBE (K922665) | Bivona Medical Technologies | 1993-01-07 |
| BIVONA FOME-CUF ADJUSTABLE TRACHEOSTOMY TUBE (K894613) | Bivona Medical Technologies | 1989-10-13 |
| BIVONA AIRE-CUF ADJUSTABLE TRACHEOSTOMY TUBE (K894614) | Bivona Medical Technologies | 1989-10-13 |