Recall record at a glance
| Official record | Z-1050-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Hospira Inc. |
| Report date | Feb 11, 2015 |
| Recall initiation date | Jun 11, 2014 |
| Quantity | 102 infusors |
| Location | Lake Forest, IL, United States |
Official 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.
Why the product was recalled
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.
Distribution information
US Distribution to New York.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Telephone.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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