Recall Z-1166-2007 ยท FPA Set, Administration, Intravascular
ICU Medical, Inc.
Orbit 90 Subcutaneous Infusion Set, 9 mm Catheter, 42" Tubing - Blue, List #P4291
| Date | Aug 16, 2007 (initiated Sep 26, 2006) |
| Status | Terminated |
| Reason | The product contains a female luer which has been reported to crack in use allowing fluid to leak from the device. |
| Root cause | Other |
| Action | Firm mailed a letter dated September 26, 2006 to notify customers of the recall. The letter advises the product contains a female luer which has been reported to crack in use allowing fluid to leak from the device. Customers are asked that if they have inventory of the lots identified to quarantine these lots and contact your consignees of this recall and return the product immediately for destruction. They are asked to complete and return the attached product inventory summary sheet in the enclosed self-addressed stamped envelope and return product to ICU Medical. |
| Quantity | 26,361 units |
| Distribution | VA, OH, TX, CA, GA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033290 | TALON INFUSION SET, MODEL IP XXXX Icu Medical, Inc., Apr 12, 2004 |