Recall Z-3213-2017 ยท JOH Tube Tracheostomy And Tube Cuff
Smiths Medical ASD Inc.
UniPerc(R) Adjustable Flange Tracheostomy Tube kit, Reorder Number 100/897/080 CZ The UniPerc(R) Tracheostomy Tubes can be used during the surgical placement of a stoma or as a replacement tube to an already existing stoma for patients with larger necks. The tracheostomy tubes are removed and may be replaced after no more than 30 days with an identical device. The range may include the follow
| Date | Aug 14, 2017 |
| Status | Terminated |
| Reason | Smiths Medical became aware that one lot of the 8.0mm UniPerc(R) Adjustable Flange Tracheostomy Tube kit, product reorder number 100/897/080 CZ, lot number 3308971, contains an incorrect 9.0mm sized obturator instead of the correct 8.0mm sized obturator. |
| Root cause | Under Investigation by firm |
| Action | Smiths Medical sent an Urgent Medical Device Recall letter dated August 7, 2017. The consignees were directed to identify the recalled product, return it to Stericycle, and respond to the recalling firm within 10 days of receipt. For further questions, please call (763) 383-3000. |
| Quantity | 89 units |
| Distribution | INTERNATIONAL ONLY: GB, FR, AT, DE, IT, SE, IE, BE, ES, LU |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962175 | PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE Smiths Industries Medical Systems, Inc., Jan 17, 1997 |