Recall Z-1050-2015— Hospira Inc.

Name: FDA recall Z-1050-2015
Creator: U.S. Food and Drug Administration
Published: 2014-06-11

Class II · Terminated

Class II FDA medical device recall by Hospira Inc., initiated 2014-06-11, terminated 2016-11-28. It names one FDA 510(k) clearance: K042081. Product: Plum A+ Infusion System with Hospira MedNet List 20792-04-25, Pole Clamp Assembly Part Number 820-95443-008. A cassette based multi-function infusion system. Each system includes a pumping module and an assortment of disposable IV sets, optional accessories, and an operator's manual. The pole clamp assembly is used to provide a mechanism to tighten and loosen the grip of the pole clamp to remove the infuser from the IV pole.. Reason: Plum A+ infusion system pole clamp assemblies were discovered to be cracked. If the knob on the pole clamp assembly is cracked, the infuser cannot be attached to the IV pole since the knob is used to tighten and loosen the grip of the pole clamp to the pole..

Recalling firm: Hospira Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-06-11
Terminated: 2016-11-28
Firm location: Lake Forest, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K042081 — PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWAREHospira, Inc.·cleared 2004-08-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Plum A+ Infusion System with Hospira MedNet List 20792-04-25, Pole Clamp Assembly Part Number 820-95443-008. A cassette based multi-function infusion system. Each system includes a pumping module and an assortment of disposable IV sets, optional accessories, and an operator's manual. The pole clamp assembly is used to provide a mechanism to tighten and loosen the grip of the pole clamp to remove the infuser from the IV pole.

Reason for recall

Plum A+ infusion system pole clamp assemblies were discovered to be cracked. If the knob on the pole clamp assembly is cracked, the infuser cannot be attached to the IV pole since the knob is used to tighten and loosen the grip of the pole clamp to the pole.

Data sourced from openFDA. This site is unofficial and independent of the FDA.