FDA Medical Device Recalls (openFDA)
Carefusion 303 Inc: CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient's artery or vein.
- Recall number
- Z-0832-2013
- Recalling firm
- Carefusion 303 Inc
- Product
- CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient's artery or vein.
- Status
- Terminated
- Initiated
- 2012-12-20
- Posted
- 2013-02-15
- Terminated
- 2013-07-25
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 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).
- Quantity
- 5,050 units
- Distribution
- Nationwide Distribution including the states of AK, CA, CO, IL, MO, NV, NY, TX and UT.
- Lot, serial or model codes
- Lot number 12055225
- 510(k) numbers
- ["K882302"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 3003879246
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28