Plum A+ Infusion System with Hospira MedNet List 20792-04-25, Pole Clamp Assembly Part Number 820-95443-008. A cassette
FDA device recall Z-1050-2015 · posted 2015-02-04 · Terminated
Recall details
- Recalling firm
- Hospira Inc.
- 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.
- Action taken
- Hospira contacted the the sole customer on June 11, 2014, to inform them of the issue of the potential impact to their Plum A+ infusers list 20792-04-25. Hospira requested that the customer to allow Hospira Field Service Representatives to inspect and replace the impact pole clamp assemblies. On June 12, 2013 Geneva Hospital approved Hospira's request to the inspection and replacement of the impacted pole clamp assemblies. On June 16, 2013 Hospira's Field Service personnel performed the on-site, visual inspection of the pole clamp assemblies and confirmed 15 units were cracked. Hospira determined to replace all 102 pole clamp assemblies that were received by Geneva Hospital. For further questions please call (800) 441- 4100.
- Root cause
- Vendor change control
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 102 infusors
- Distribution
- US Distribution to New York.
- Date initiated
- 2014-06-11
- Date posted
- 2015-02-04
- Date terminated
- 2016-11-28
- Location
- Lake Forest, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE (K042081) | Hospira, Inc. | 2004-08-24 |