Recall record at a glance
| Official record | Z-2433-2024 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | B Braun Medical Inc. |
| Report date | Jul 31, 2024 |
| Recall initiation date | Jun 14, 2024 |
| Quantity | 14949 |
| Location | Breinigsville, PA, United States |
Official product description
Brand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump System Model/Catalog Number: 8713030U Product Description: Perfusor Space Infusion Pump System, Infusion Pump, 1 each Component: N/A
Why the product was recalled
Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may result in issues with recognition, compatibility, and pump performance, such as overdose, underdose, delay in therapy, delay in occlusion alarms, and delay in feeding. Cardinal Health Monoject syringes are not compatible with the indicated pumps.
Distribution information
Domestic distribution nationwide. International distribution to Canada.
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: Letter.
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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