FDA Medical Device Recalls (openFDA)
Hospira Inc.: *** 1) Product labeled in part: List No. 14220-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, CLAVE Y-Site, Non-Vented, 110 Inch, Non-DEHP; Product Usage: The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.
- Recall number
- Z-2060-2016
- Recalling firm
- Hospira Inc.
- Product
- *** 1) Product labeled in part: List No. 14220-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, CLAVE Y-Site, Non-Vented, 110 Inch, Non-DEHP; Product Usage: The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.
- Status
- Terminated
- Initiated
- 2013-09-09
- Posted
- not on file
- Terminated
- 2016-12-06
- Reason
- Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
- Root cause
- Device Design
- Action
- Hospira sent an URGENT MEDICAL DEVICE CORECTION letters dated September 9, 2013 to customers. The letter identified the affected product, problem and actions to be taken. the letter included additional instructions on the proper handling/use of the CLAVE devices. The letters request that all incidents of separation or breakage of CLAVE from the secondary port of the cassette be reported to Hospira by calling 1-800-441-410 (Monday - Friday, 8:00 AM - 5:00 PM CST) or by e-mail at ProductComplaintPP@hospira.com. Customers are further requested to complete and return a response form included wih the URGENT MEDICAL DEVICE CORRECTION letter and to notify any customers of this advisory. Hospira will also be supplementing the instructions for CLAVE use as an interim measure until a new method for bonding the CLAVE to the secondary port of the Plum cassettes can be devised and implemented.
- Quantity
- 3,920,932 units in total
- Distribution
- US (Nationwide) Distribution
- Lot, serial or model codes
- ***** CANADA DISTRIBUTION ***** *** 1) List Number 14220-28-01
- 510(k) numbers
- ["K101677"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 3013319212
- Firm city
- Lake Forest
- Firm state
- IL
- 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