Recall Z-2060-2016
Hospira Inc. · initiated September 9, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: ***** CANADA DISTRIBUTION ***** *** 1) List Number 14220-28-01
Reason for recall
Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-2060-2016
- Initiated
- September 9, 2013
- Terminated
- December 6, 2016
- Product code
- FPA – Set, Administration, Intravascular
- Quantity
- 3,920,932 units in total
- Distribution
- US (Nationwide) Distribution
- Recalling firm
- Hospira Inc., Lake Forest, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2058-2016 Class II | *** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BLOOD SET…Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets. | 09/09/2013Terminated |
| Z-2059-2016 Class II | *** 1) Product labeled in part: 14951-48; LIFESHIELD; PLUMSET WITH CONVERTIBLE PIERCING…Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets. | 09/09/2013Terminated |
| Z-2061-2016 Class II | *** 1) Product labeled in part: 19734-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET…Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets. | 09/09/2013Terminated |
| Z-2062-2016 Class II | *** 1) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH 1.2 MICRON…Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets. | 09/09/2013Terminated |