CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or cat
FDA device recall Z-0832-2013 · posted 2013-02-15 · Terminated
Recall details
- Recalling firm
- Carefusion 303 Inc
- Reason for recall
- CareFusion is recalling the SmartSite Gravity Blood Set as a result of a potential for separation at the connection of the drip chamber and tubing . The separation may be observed at priming or observed during use. If a separation between the drip chamber and tubing occurs, this could cause a delay in treatment.
- Action taken
- Carefusion sent an "URGENT: Medical Device Recall Notification" letter dated January 21, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to return all recalled product directly to the distributor from whom it was purchased immediately, complete and return the enclosed pre-addressed and postage paid mandatory Customer Recall Response Card and to contact your distributor directly, or call the Carefusion Support Center, if you have any questions. For questions Recall Related Questions contact CareFusion Support Center at 888-562-6018; 7am to 4pm (Pacific). For technical questions contact Technical Support at 888-812-3229, 7am to 5pm (Pacific).
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 5,050 units
- Distribution
- Nationwide Distribution including the states of AK, CA, CO, IL, MO, NV, NY, TX and UT.
- Date initiated
- 2012-12-20
- Date posted
- 2013-02-15
- Date terminated
- 2013-07-25
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080 (K882302) | Y | 1988-07-12 |