Orbit 90 Subcutaneous Infusion Set, 9 mm Catheter, 42" Tubing - Blue, List #P4291
FDA device recall Z-1166-2007 · posted 2007-08-16 · Terminated
Recall details
- Recalling firm
- ICU Medical, Inc.
- Reason for recall
- The product contains a female luer which has been reported to crack in use allowing fluid to leak from the device.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 26,361 units
- Distribution
- VA, OH, TX, CA, GA
- Date initiated
- 2006-09-26
- Date posted
- 2007-08-16
- Date terminated
- 2012-03-22
- Location
- San Clemente, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TALON INFUSION SET, MODEL IP XXXX (K033290) | Icu Medical, Inc. | 2004-04-12 |