Monitoring Kit with 03mL Flush Device, Item No. 46080-57 Product Usage: The Transpac Disposable Straight Pressure Transd
FDA device recall Z-2818-2016 · posted 2016-09-15 · Terminated
Recall details
- Recalling firm
- ICU Medical, Inc.
- Reason for recall
- ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
- Action taken
- An Urgent Medical Device Recall Notification letter dated 8/10/16 was sent to all their customers who purchased the Transpac IV with SafeSet reservoir kit and without SafeSet Reservoir, and with Transpac IV with marvelous valve without SafeSet reservoir. The letter informs the customers that ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. The recall letter list the affected products and lot numbers. Customers are informed of the actions to be taken. Customers with questions are instructed to contact ICU Customer Service Monday through Friday between the hours of 8:30 AM and 4:00 PM Pacific time: 866-829-9025 and select option 8, or e-mail the following address: customerservice@icumed.com. Customers are instructed to complete the attached Medical Device Recall Response Form and fax to (801) 264-1755 or e-mail to recall@icumed.com.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DRS
- Quantity affected
- 70 units
- Distribution
- US Nationwide Distribution
- Date initiated
- 2016-08-10
- Date posted
- 2016-09-15
- Date terminated
- 2017-07-10
- 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 |
| SAFESET RESERVOIR (K932188) | Abbott Laboratories | 1993-10-25 |