Single Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve, Macrodrip, Item No. 011-46106-29 Transpac Trif
FDA device recall Z-2161-2014 · posted 2014-08-07 · Terminated
Recall details
- Recalling firm
- ICU Medical, Inc.
- Reason for recall
- ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.
- Action taken
- ICU Medical, Inc. sent an email dated July 18, 2014, to their customers, The email inform the customer of the problem and the action to be taken. The email stated that the US Sales Representative would remove the recalled product on July 22, 2014. If product was further distribution customers should notify their customers. Customer was informed of the RGA to have the recalled product returned. For questions regarding this recall call 801-264-1732.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DRS
- Quantity affected
- 200 units
- Distribution
- Worldwide Distribution - USA including Oregon and Internationally to Australia.
- Date initiated
- 2014-07-18
- Date posted
- 2014-08-07
- Date terminated
- 2014-09-25
- Location
- San Clemente, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT (K061573) | Hospira, Inc. | 2006-09-19 |