MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305
FDA device recall Z-1464-2017 · posted 2017-02-28 · Terminated
Recall details
- Recalling firm
- CareFusion 303, Inc.
- Reason for recall
- CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter because of reports of separation and/or leakages between the Y-connector and tubing.
- Action taken
- An Urgent Medical Device Recall Notification letter will be sent to customers on February 20, 2017 to inform them that CareFusion is recalling the MaxGuard Extension Set with Injection Site and 0.2 micron filter model number ME3305 Lot Number 16016790. Customers are informed that CareFusion has received reports of separation and/or leakages between theY-connector and tubing. Customers are informed that leakages from an extension set can cause delay of infusion, interruption of infusion, exposure to medication or hazardous infusates, or underinfusion. The letter informs the customers of the actions to be taken and for recall related questions to contact CareFusion Support Center at (888) 562-6018. Customers with adverse event reports are instructed to contact customer advocacy at (888) 812-3266.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 1,200 units
- Distribution
- US Distribution including MA and MD
- Date initiated
- 2017-02-20
- Date posted
- 2017-02-28
- Date terminated
- 2017-11-17
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET (K051499) | Medegen Medical Manufacturing Services | 2005-06-22 |