Recall Z-0139-2010 ยท BTO Tube, Tracheostomy (W/Wo Connector)
Gf Health Products, Inc.
John Bunn 1392 Series Jackson Tracheostomy Stainless Steel Tube.
| Date | Nov 9, 2009 (initiated Sep 14, 2009) |
| Status | Terminated |
| Reason | Incorrect material. Manufacturer changed the material of the trach tube from Stainless Steel to German silver/nickel, contrary to product specifications. |
| Root cause | Nonconforming Material/Component |
| Action | GF Health Products (Graham Field) notified consignees by certified US Mail on/about 09/14/2009. The distribution to the dealers includes the announcement of the recall to the dealer the letter to send to the end users and a Proof of Compliance card for the dealer to submit to Graham Field following completion of the recall instructions. Graham-Field instructed the dealers to return any impacted products on site, as well as any delivered by end-users, customers or other impacted third parties. Dealer will be compensated for executing the recall. Graham Field does not have direct access to end u |
| Quantity | 396 units |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.