FDA Device recall Z-2058-2016
*** 1) Product labeled in part: List No. 14212-28
- FDA Device
- Class II
- terminated
- Published 2016-07-06
On 2016-07-06 the FDA classified a Class II recall of *** 1) Product labeled in part: List No. 14212-28 by Hospira, citing intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2058-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-09 |
| Published | 2016-07-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Hospira |
| Distribution | US |
Product
*** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 Inch, Non-DEHP; *** 2) Product labeled in part: List No. 14254-28; LIFESHIELD; PRIMARY PLUMSET; CLAVE Port 2 CLAVE Y-Sites, 0.2 Micron Filter, 112 Inch, Non-DEHP; *** 3) Product labeled in part: List No. 14687-28; LIFESHIELD; PRIMARY PLUMSET; CLAVE Port, CLAVE Y-Site; 103 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.
Reason
Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
Identifiers
| code_info | ***** US DISTRIBUTION ***** *** 1) List Number: 14212-04-28; Lot Numbers: 962235H , 030565H , 030575H , 081425…***** US DISTRIBUTION ***** *** 1) List Number: 14212-04-28; Lot Numbers: 962235H , 030565H , 030575H , 081425H , 090515H , 100905H , 100915H , 102255H , 102265H , 122515H , 122525H , 143405H , 152655H , 152665H , 152675H , 161375H , 161385H , 161395H , 170955H , 172025H , 172035H , 172045H , 143415H , 241805H , 251735H , 251745H , 250845H ; *** 2) List Number: 14254-08-28; Lot Number: 072055H; *** 3) List Number: 14687-04-28; Lot Numbers: 650935H , 710435H , 720925H , 721925H , 721895H , 721325H , 721905H , 730175H , 761965H , 771895H , 772175H , 780725H , 781395H , 780715H , 800135H , 800145H , 810185H , 851685H , 840795H , 861775H , 861785H , 810155H , 880695H , 901065H , 901055H , 901095H , 921945H , 020765H , 020775H , 020785H , 020795H , 030185H , 030195H , 042005H , 052335H , 052755H , 052345H , 061035H , 070625H , 080325H , 080335H , 091085H , 092935H , 132125H , 142805H , 153285H , 153495H , |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2058-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.